ALBUMIN IODINATED I-125 SERUM | 500uCi/0.5ML | INJECTABLE;INJECTION | JEANATOPE | ISO TEX DIAGNOSTICS INC | NDA | Approved Prior to Jan 1, 1982 | RX |
ALBUMIN IODINATED I-131 SERUM | 0.5mCi/VIAL | INJECTABLE;INJECTION | MEGATOPE | ISO TEX DIAGNOSTICS INC | NDA | Approved Prior to Jan 1, 1982 | RX |
AMINO ACIDS | 5.4% (5.4GM/100ML) | INJECTABLE;INJECTION | NEPHRAMINE 5.4% | B BRAUN MEDICAL INC | NDA | Approved Prior to Jan 1, 1982 | RX |
ARGININE HYDROCHLORIDE | 10GM/100ML | INJECTABLE;INJECTION | R-GENE 10 | PHARMACIA AND UPJOHN CO | NDA | Approved Prior to Jan 1, 1982 | RX |
BACITRACIN | 10,000 UNITS/VIAL | INJECTABLE;INJECTION | BACITRACIN | PHARMACIA AND UPJOHN CO | ANDA | Approved Prior to Jan 1, 1982 | RX |
BENZYLPENICILLOYL POLYLYSINE | 60UMOLAR | INJECTABLE;INJECTION | PRE-PEN | ALLERQUEST LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
BUSULFAN | 2MG | TABLET;ORAL | MYLERAN | ASPEN GLOBAL INC | NDA | Approved Prior to Jan 1, 1982 | RX |
CAPREOMYCIN SULFATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | CAPASTAT SULFATE | AKORN INC | NDA | Approved Prior to Jan 1, 1982 | RX |
CARBOPROST TROMETHAMINE | EQ 0.25MG BASE/ML | INJECTABLE;INJECTION | HEMABATE | PHARMACIA AND UPJOHN CO | NDA | Approved Prior to Jan 1, 1982 | RX |
CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | BICNU | EMCURE PHARMACEUTICALS LTD | NDA | Approved Prior to Jan 1, 1982 | RX |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE | 5MG;2.5MG | CAPSULE;ORAL | LIBRAX | VALEANT PHARMACEUTICALS NORTH AMERICA LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
CHLOROPROCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | NESACAINE | FRESENIUS KABI USA LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
CHLOROTHIAZIDE | 250MG/5ML | SUSPENSION;ORAL | DIURIL | SALIX PHARMACEUTICALS INC | NDA | Approved Prior to Jan 1, 1982 | RX |
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | 8MG;120MG | TABLET, EXTENDED RELEASE;ORAL | CHLOR-TRIMETON | BAYER HEALTHCARE LLC | NDA | Approved Prior to Jan 1, 1982 | OTC |
CLOCORTOLONE PIVALATE | 0.10% | CREAM;TOPICAL | CLODERM | PROMIUS PHARMA LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE | EQ 3MG BASE/ML; 10MG/ML; EQ 3.3MG BASE/ML; 0.5MG/ML | SUSPENSION/DROPS;OTIC | COLY-MYCIN S | ENDO PHARMACEUTICALS INC | NDA | Approved Prior to Jan 1, 1982 | RX |
CROTAMITON | 10% | CREAM;TOPICAL | EURAX | RANBAXY LABORATORIES INC | NDA | Approved Prior to Jan 1, 1982 | RX |
CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE | 0.2%;1% | SOLUTION/DROPS;OPHTHALMIC | CYCLOMYDRIL | NOVARTIS PHARMACEUTICALS CORP | ANDA | Approved Prior to Jan 1, 1982 | RX |
CYCLOSERINE | 250MG | CAPSULE;ORAL | SEROMYCIN | PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY | ANDA | Approved Prior to Jan 1, 1982 | RX |
DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE | 5GM/100ML; 32MG/100ML; 128MG/100ML; 234MG/100ML | INJECTABLE;INJECTION | PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | Approved Prior to Jan 1, 1982 | RX |
DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE | 5GM/100ML; 21MG/100ML; 128MG/100ML; 234MG/100ML | INJECTABLE;INJECTION | NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER | ICU MEDICAL INC | NDA | Approved Prior to Jan 1, 1982 | RX |
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE | 5GM/100ML; 31MG/100ML; 141MG/100ML; 20MG/100ML; 12MG/100ML; 260MG/100ML | INJECTABLE;INJECTION | DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | Approved Prior to Jan 1, 1982 | RX |
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 5GM/100ML; 30MG/100ML; 37MG/100ML; 222MG/100ML; 526MG/100ML; 502MG/100ML | INJECTABLE;INJECTION | NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER | ICU MEDICAL INC | NDA | Approved Prior to Jan 1, 1982 | RX |
DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;149MG/100ML | INJECTABLE;INJECTION | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER | ICU MEDICAL INC | NDA | Approved Prior to Jan 1, 1982 | RX |
DIAZOXIDE | 50MG/ML | SUSPENSION;ORAL | PROGLYCEM | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC | NDA | Approved Prior to Jan 1, 1982 | RX |
DIMERCAPROL | 10% | INJECTABLE;INJECTION | BAL | AKORN INC | NDA | Approved Prior to Jan 1, 1982 | RX |
DINOPROSTONE | 20MG | SUPPOSITORY;VAGINAL | PROSTIN E2 | PHARMACIA AND UPJOHN CO | NDA | Approved Prior to Jan 1, 1982 | RX |
DOXYCYCLINE CALCIUM | EQ 50MG BASE/5ML | SUSPENSION;ORAL | VIBRAMYCIN | PFIZER LABORATORIES DIV PFIZER INC | NDA | Approved Prior to Jan 1, 1982 | RX |
ECHOTHIOPHATE IODIDE | 0.13% | FOR SOLUTION;OPHTHALMIC | PHOSPHOLINE IODIDE | WYETH PHARMACEUTICALS INC | NDA | Approved Prior to Jan 1, 1982 | RX |
EDETATE CALCIUM DISODIUM | 200MG/ML | INJECTABLE;INJECTION | CALCIUM DISODIUM VERSENATE | MEDICIS PHARMACEUTICAL CORP | NDA | Approved Prior to Jan 1, 1982 | RX |
ERYTHROMYCIN | 250MG | TABLET;ORAL | ERYTHROMYCIN | ARBOR PHARMACEUTICALS LLC | ANDA | Approved Prior to Jan 1, 1982 | RX |
ESTRAMUSTINE PHOSPHATE SODIUM | EQ 140MG PHOSPHATE | CAPSULE;ORAL | EMCYT | PHARMACIA AND UPJOHN CO | NDA | Approved Prior to Jan 1, 1982 | RX |
ESTROGENS, CONJUGATED | 0.625MG/GM | CREAM;TOPICAL, VAGINAL | PREMARIN | WYETH PHARMACEUTICALS INC | NDA | Approved Prior to Jan 1, 1982 | RX |
ESTROGENS, CONJUGATED | 25MG/VIAL | INJECTABLE;INJECTION | PREMARIN | WYETH PHARMACEUTICALS INC | NDA | Approved Prior to Jan 1, 1982 | RX |
ESTROGENS, CONJUGATED | 1.25MG | TABLET;ORAL | PREMARIN | WYETH PHARMACEUTICALS INC | NDA | Approved Prior to Jan 1, 1982 | RX |
ETHIODIZED OIL | EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML) | OIL;INTRALYMPHATIC, INTRAUTERINE | LIPIODOL | GUERBET LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
ETHOTOIN | 250MG | TABLET;ORAL | PEGANONE | RECORDATI RARE DISEASES INC | NDA | Approved Prior to Jan 1, 1982 | RX |
FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE | 0.025%;EQ 3.5MG BASE/GM | CREAM;TOPICAL | NEO-SYNALAR | MEDIMETRIKS PHARMACEUTICALS INC | ANDA | Approved Prior to Jan 1, 1982 | RX |
FLUOROURACIL | 1% | CREAM;TOPICAL | FLUOROPLEX | AQUA PHARMACEUTICALS LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
FLURANDRENOLIDE | 0.004MG/SQ CM | TAPE;TOPICAL | CORDRAN | ALLERGAN SALES LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
GUANIDINE HYDROCHLORIDE | 125MG | TABLET;ORAL | GUANIDINE HYDROCHLORIDE | MERCK SHARP AND DOHME CORP | NDA | Approved Prior to Jan 1, 1982 | RX |
HALCINONIDE | 0.10% | OINTMENT;TOPICAL | HALOG | RANBAXY LABORATORIES INC | NDA | Approved Prior to Jan 1, 1982 | RX |
HYDROCORTISONE | 2% | LOTION;TOPICAL | ALA-SCALP | CROWN LABORATORIES INC | ANDA | Approved Prior to Jan 1, 1982 | RX |
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 0.5%;1% | CREAM;TOPICAL | PRAMOSONE | SEBELA IRELAND LTD | ANDA | Approved Prior to Jan 1, 1982 | RX |
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 1%;1% | CREAM;TOPICAL | PRAMOSONE | SEBELA IRELAND LTD | ANDA | Approved Prior to Jan 1, 1982 | RX |
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 1%;1% | LOTION;TOPICAL | PRAMOSONE | SEBELA IRELAND LTD | ANDA | Approved Prior to Jan 1, 1982 | RX |
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 2.5%;1% | LOTION;TOPICAL | PRAMOSONE | SEBELA IRELAND LTD | ANDA | Approved Prior to Jan 1, 1982 | RX |
HYDROXYPROPYL CELLULOSE | 5MG | INSERT;OPHTHALMIC | LACRISERT | ATON PHARMA INC | NDA | Approved Prior to Jan 1, 1982 | RX |
IOTHALAMATE MEGLUMINE | 30% | INJECTABLE;INJECTION | CONRAY 30 | LIEBEL-FLARSHEIM CO LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
IOTHALAMATE MEGLUMINE | 60% | INJECTABLE;INJECTION | CONRAY | LIEBEL-FLARSHEIM CO LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
IOTHALAMATE SODIUM I-125 | 250-300uCi/ML | INJECTABLE;INJECTION | GLOFIL-125 | ISOTEX DIAGNOSTICS | NDA | Approved Prior to Jan 1, 1982 | RX |
ISOCARBOXAZID | 10MG | TABLET;ORAL | MARPLAN | VALIDUS PHARMACEUTICALS INC | NDA | Approved Prior to Jan 1, 1982 | RX |
LIOTRIX (T4;T3) | 0.0125MG;0.0031MG | TABLET;ORAL | THYROLAR-0.25 | FOREST LABORATORIES INC | NDA | Approved Prior to Jan 1, 1982 | RX |
LOMUSTINE | 10MG | CAPSULE;ORAL | GLEOSTINE | CORDEN PHARMA LATINA SPA | NDA | Approved Prior to Jan 1, 1982 | RX |
MAFENIDE ACETATE | EQ 85MG BASE/GM | CREAM;TOPICAL | SULFAMYLON | MYLAN INSTITUTIONAL INC | NDA | Approved Prior to Jan 1, 1982 | RX |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML; 37MG/100ML; 222MG/100ML; 526MG/100ML; 502MG/100ML | INJECTABLE;INJECTION | NORMOSOL-R IN PLASTIC CONTAINER | ICU MEDICAL INC | NDA | Approved Prior to Jan 1, 1982 | RX |
MECHLORETHAMINE HYDROCHLORIDE | 10MG/VIAL | INJECTABLE;INJECTION | MUSTARGEN | RECORDATI RARE DISEASES INC | NDA | Approved Prior to Jan 1, 1982 | RX |
METHADONE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | METHADONE HYDROCHLORIDE | MYLAN INSTITUTIONAL LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
METHOHEXITAL SODIUM | 500MG/VIAL | INJECTABLE;INJECTION | BREVITAL SODIUM | PAR STERILE PRODUCTS LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
METYROSINE | 250MG | CAPSULE;ORAL | DEMSER | ATON PHARMA DIV VALEANT PHARMACEUTICALS NORTH AMERICA LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
MITOTANE | 500MG | TABLET;ORAL | LYSODREN | BRISTOL MYERS SQUIBB | NDA | Approved Prior to Jan 1, 1982 | RX |
NATAMYCIN | 5% | SUSPENSION;OPHTHALMIC | NATACYN | NOVARTIS PHARMACEUTICALS CORP | NDA | Approved Prior to Jan 1, 1982 | RX |
OXTRIPHYLLINE | 600MG | TABLET, EXTENDED RELEASE;ORAL | CHOLEDYL SA | WARNER CHILCOTT CO LLC | ANDA | Approved Prior to Jan 1, 1982 | RX |
OXYMETHOLONE | 50MG | TABLET;ORAL | ANADROL-50 | MYLAN SPECIALTY LP | NDA | Approved Prior to Jan 1, 1982 | RX |
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE | EQ 5MG BASE/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | TERRAMYCIN W/ POLYMYXIN B SULFATE | PFIZER LABORATORIES DIV PFIZER INC | ANDA | Approved Prior to Jan 1, 1982 | RX |
PENICILLAMINE | 250MG | CAPSULE;ORAL | CUPRIMINE | ATON PHARMA INC | NDA | Approved Prior to Jan 1, 1982 | RX |
PENICILLAMINE | 250MG | TABLET;ORAL | DEPEN | MYLAN SPECIALTY LP | NDA | Approved Prior to Jan 1, 1982 | RX |
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE;INJECTION | BICILLIN C-R | KING PHARMACEUTICALS LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
PENTAZOCINE LACTATE | EQ 30MG BASE/ML | INJECTABLE;INJECTION | TALWIN | HOSPIRA INC | NDA | Approved Prior to Jan 1, 1982 | RX |
PRALIDOXIME CHLORIDE | 1GM/VIAL | INJECTABLE;INJECTION | PROTOPAM CHLORIDE | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | NDA | Approved Prior to Jan 1, 1982 | RX |
PREDNISOLONE ACETATE | 0.12% | SUSPENSION/DROPS;OPHTHALMIC | PRED MILD | ALLERGAN PHARMACEUTICAL | NDA | Approved Prior to Jan 1, 1982 | RX |
PROCARBAZINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | MATULANE | LEADIANT BIOSCIENCES INC | NDA | Approved Prior to Jan 1, 1982 | RX |
PSEUDOEPHEDRINE SULFATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | AFRINOL | SCHERING PLOUGH HEALTHCARE PRODUCTS INC | NDA | Approved Prior to Jan 1, 1982 | OTC |
PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | MESTINON | VALEANT PHARMACEUTICALS NORTH AMERICA LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
PYRIMETHAMINE | 25MG | TABLET;ORAL | DARAPRIM | TURING PHARMACEUTICALS AG | NDA | Approved Prior to Jan 1, 1982 | RX |
SODIUM IODIDE I-131 | 3.5-150mCi/VIAL | SOLUTION;ORAL | SODIUM IODIDE I 131 | MALLINCKRODT NUCLEAR MEDICINE LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
SORBITOL | 3.3GM/100ML | SOLUTION;IRRIGATION | SORBITOL 3.3% IN PLASTIC CONTAINER | B BRAUN MEDICAL INC | NDA | Approved Prior to Jan 1, 1982 | RX |
TECHNETIUM TC-99M OXIDRONATE KIT | N/A | INJECTABLE;INJECTION | TECHNESCAN | MALLINCKRODT NUCLEAR MEDICINE LLC | NDA | Approved Prior to Jan 1, 1982 | RX |
TESTOSTERONE | 75MG | PELLET;IMPLANTATION | TESTOPEL | AUXILIUM PHARMACEUTICALS INC | ANDA | Approved Prior to Jan 1, 1982 | RX |
TETRAHYDROZOLINE HYDROCHLORIDE | 0.10% | SOLUTION;NASAL | TYZINE | FOUGERA PHARMACEUTICALS INC | ANDA | Approved Prior to Jan 1, 1982 | RX |
THIOGUANINE | 40MG | TABLET;ORAL | THIOGUANINE | ASPEN GLOBAL INC | NDA | Approved Prior to Jan 1, 1982 | RX |
TOBRAMYCIN | 0.30% | OINTMENT;OPHTHALMIC | TOBREX | NOVARTIS PHARMACEUTICALS CORP | NDA | Approved Prior to Jan 1, 1982 | RX |
TRIAMCINOLONE HEXACETONIDE | 5MG/ML | INJECTABLE;INJECTION | ARISTOSPAN | SANDOZ CANADA INC | NDA | Approved Prior to Jan 1, 1982 | RX |
TRIAMTERENE | 50MG | CAPSULE;ORAL | DYRENIUM | CONCORDIA PHARMACEUTICALS INC | NDA | Approved Prior to Jan 1, 1982 | RX |
TALC | 2GM/VIAL | POWDER;INTRAPLEURAL | STERITALC | NOVATECH SA | NDA | 01-May-17 | RX |
ABALOPARATIDE | 3.12MG/1.56ML (2MG/ML) | SOLUTION;SUBCUTANEOUS | TYMLOS | RADIUS HEALTH INC | NDA | 28-Apr-17 | RX |
BRIGATINIB | 30MG | TABLET;ORAL | ALUNBRIG | ARIAD PHARMACEUTICALS INC | NDA | 28-Apr-17 | RX |
ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.01MG;0.01MG,N/A | TABLET;ORAL | LO SIMPESSE | AUROBINDO PHARMA LTD | ANDA | 28-Apr-17 | RX |
MIDOSTAURIN | 25MG | CAPSULE;ORAL | RYDAPT | NOVARTIS PHARMACEUTICALS CORP | NDA | 28-Apr-17 | RX |
ATORVASTATIN CALCIUM; EZETIMIBE | EQ 10MG BASE;10MG | TABLET;ORAL | EZETIMIBE AND ATORVASTATIN CALCIUM | WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | ANDA | 26-Apr-17 | RX |
METHOTREXATE SODIUM | EQ 2.5MG BASE/ML | SOLUTION;ORAL | XATMEP | SILVERGATE PHARMACEUTICALS INC | NDA | 25-Apr-17 | RX |
CLINDAMYCIN PHOSPHATE | EQ 300MG BASE/50ML (EQ 6MG BASE/ML) | SOLUTION;IV (INFUSION) | CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | CELERITY PHARMACEUTICALS LLC | NDA | 20-Apr-17 | RX |
VORICONAZOLE | 200MG/VIAL | POWDER;IV (INFUSION) | VORICONAZOLE | XELLIA PHARMACEUTICALS APS | NDA | 09-Mar-17 | RX |
SODIUM NITROPRUSSIDE | 50MG/100ML (0.5MG/ML) | SOLUTION;IV (INFUSION) | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | EXELA PHARMA SCIENCES LLC | NDA | 08-Mar-17 | RX |
DOCETAXEL | 40MG/ML | INJECTABLE;INJECTION | DOCETAXEL | JIANGSU HENGRUI MEDICINE CO LTD | ANDA | 15-Feb-17 | RX |
DEFLAZACORT | 22.75MG/ML | SUSPENSION;ORAL | EMFLAZA | PTC THERAPEUTICS INC | NDA | 09-Feb-17 | RX |
DEFLAZACORT | 6MG | TABLET;ORAL | EMFLAZA | PTC THERAPEUTICS INC | NDA | 09-Feb-17 | RX |
ETELCALCETIDE | 2.5MG/0.5ML (2.5MG/0.5ML) | SOLUTION;INTRAVENOUS | PARSABIV | KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC | NDA | 07-Feb-17 | RX |
EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;IV (INFUSION) | CORPHEDRA | PAR STERILE PRODUCTS LLC | NDA | 27-Jan-17 | RX |
THIOTEPA | 15MG/VIAL | POWDER;IV (INFUSION) | TEPADINA | ADIENNE SA | NDA | 26-Jan-17 | RX |
PIRFENIDONE | 267MG | TABLET;ORAL | ESBRIET | GENENTECH INC | NDA | 11-Jan-17 | RX |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | POWDER;ORAL | COLPREP KIT | GATOR PHARMACEUTICALS INC | NDA | 27-Dec-16 | RX |
LEVOTHYROXINE SODIUM | 13MCG/ML | SOLUTION;ORAL | TIROSINT-SOL | INSTITUT BIOCHIMIQUE SA (IBSA) | NDA | 15-Dec-16 | RX |
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 20MG;20MG | TABLET, EXTENDED RELEASE;ORAL | BONJESTA | DUCHESNAY INC | NDA | 07-Nov-16 | RX |
MEBENDAZOLE | 500MG | TABLET, CHEWABLE;ORAL | VERMOX | JANSSEN PHARMACEUTICALS INC | NDA | 19-Oct-16 | RX |
BARIUM SULFATE | 40% (92GM/230ML) | PASTE;ORAL | VARIBAR | BRACCO DIAGNOSTICS INC | NDA | 14-Oct-16 | RX |
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | 325MG;30MG;16MG | TABLET;ORAL | ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE | LARKEN LABORATORIES INC | ANDA | 30-Sep-16 | RX |
RUBIDIUM CHLORIDE RB-82 | N/A | SOLUTION;INTRAVENOUS | RUBY-FILL | JUBILANT DRAXIMAGE INC | NDA | 30-Sep-16 | RX |
LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/VIAL | POWDER;IV (INFUSION) | LEVOLEUCOVORIN CALCIUM | ACTAVIS LLC | NDA | 29-Sep-16 | RX |
ENALAPRIL MALEATE | 1MG/ML | SOLUTION;ORAL | EPANED | SILVERGATE PHARMACEUTICALS INC | NDA | 20-Sep-16 | RX |
PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) | SOLUTION;INTRAVENOUS | PALONOSETRON HYDROCHLORIDE | EXELA PHARMA SCIENCES | NDA | 22-Aug-16 | RX |
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | 3GM/100ML; 6GM/100ML; 5GM/100ML; 6GM/100ML (100ML) | EMULSION;INTRAVENOUS | SMOFLIPID 20% | FRESENIUS KABI USA LLC | NDA | 13-Jul-16 | RX |
GALLIUM DOTATATE GA-68 | 2.1-5.5mCi/ML | POWDER;INTRAVENOUS | NETSPOT | ADVANCED ACCELERATOR APPLICATIONS USA INC | NDA | 01-Jun-16 | RX |
CARBINOXAMINE MALEATE | 6MG | TABLET;ORAL | CARBINOXAMINE MALEATE | MIKART INC | ANDA | 31-May-16 | RX |
DOXYCYCLINE HYCLATE | EQ 75MG BASE | CAPSULE;ORAL | ACTICLATE CAP | AQUA PHARMACEUTICALS | NDA | 26-Apr-16 | RX |
FERRIC PYROPHOSPHATE CITRATE | 272MG IRON/PACKET | FOR SOLUTION;INTRAVENOUS | TRIFERIC | ROCKWELL MEDICAL INC | NDA | 25-Apr-16 | RX |
ROPIVACAINE HYDROCHLORIDE | 5MG/ML | INJECTABLE;INJECTION | ROPIVACAINE HYDROCHLORIDE | AKORN INC | ANDA | 11-Apr-16 | RX |
METHYLENE BLUE | 50MG/10ML (5MG/ML) | SOLUTION;INTRAVENOUS | PROVAYBLUE | PROVEPHARM SAS | NDA | 08-Apr-16 | RX |
GLIMEPIRIDE; ROSIGLITAZONE MALEATE | 1MG;4MG | TABLET;ORAL | ROSIGLITAZONE MALEATE AND GLIMEPIRIDE | TEVA PHARMACEUTICALS USA | ANDA | 01-Apr-16 | RX |
DEFIBROTIDE SODIUM | 200MG/2.5ML (80MG/ML) | SOLUTION;IV (INFUSION) | DEFITELIO | JAZZ PHARMACEUTICALS INC | NDA | 30-Mar-16 | RX |
PALONOSETRON HYDROCHLORIDE | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | PALONOSETRON HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | NDA | 01-Mar-16 | RX |
TETRACAINE HYDROCHLORIDE | 0.50% | SOLUTION;OPHTHALMIC | TETRACAINE HYDROCHLORIDE | NOVARTIS PHARMACEUTICALS CORP | NDA | 29-Feb-16 | RX |
SUMATRIPTAN SUCCINATE | EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) | SOLUTION;SUBCUTANEOUS | ZEMBRACE SYMTOUCH | DR REDDYS LABORATORIES LTD | NDA | 28-Jan-16 | RX |
ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG, 0.035MG, 0.035MG;0.18MG, 0.215MG, 0.25MG | TABLET;ORAL-28 | NORGESTIMATE AND ETHINYL ESTRADIOL | MYLAN LABORATORIES LTD | ANDA | 27-Jan-16 | RX |
BARIUM SULFATE | 98% (334GM/BOTTLE) | FOR SUSPENSION;ORAL | E-Z-HD | BRACCO DIAGNOSTICS INC | NDA | 11-Jan-16 | RX |
VANCOMYCIN HYDROCHLORIDE | EQ 100GM BASE | POWDER;IV (INFUSION) | VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER | SAMSON MEDICAL TECHNOLOGIES LLC | ANDA | 06-Jan-16 | RX |
ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION;IV (INFUSION) | ZOLEDRONIC ACID | HOSPIRA INC | NDA | 28-Dec-15 | RX |
INSULIN GLARGINE | 300 UNITS/3ML (100 UNITS/ML) | SOLUTION;SUBCUTANEOUS | BASAGLAR | ELI LILLY AND CO | NDA | 16-Dec-15 | RX |
ACETAMINOPHEN; BUTALBITAL | 325MG;25MG | TABLET;ORAL | ALLZITAL | LARKEN LABORATORIES INC | ANDA | 04-Dec-15 | RX |
ISRADIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | ISRADIPINE | MYLAN PHARMACEUTICALS INC | ANDA | 27-Nov-15 | RX |
CEFOXITIN SODIUM | EQ 100GM BASE | POWDER;IV (INFUSION) | CEFOXITIN IN PLASTIC CONTAINER | SAMSON MEDICAL TECHNOLOGIES LLC | ANDA | 16-Nov-15 | RX |
AMMONIA N-13 | 30mCi-300mCi (3.75-37.5mCi/ML) | INJECTABLE;INTRAVENOUS | AMMONIA N 13 | PETNET SOLUTIONS INC | ANDA | 02-Nov-15 | RX |
DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) | SOLUTION;IV (INFUSION) | DEXMEDETOMIDINE HYDROCHLORIDE | HQ SPECIALTY PHARMA CORP | NDA | 21-Oct-15 | RX |
ASPIRIN | 162.5MG | CAPSULE, EXTENDED RELEASE;ORAL | DURLAZA | NEW HAVEN PHARMACEUTICALS INC | NDA | 04-Sep-15 | RX |
POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | POTASSIUM CHLORIDE | PHARMA RESEARCH SOFTWARE SOLUTION LLC | NDA | 19-Aug-15 | RX |
CEFAZOLIN SODIUM | EQ 2GM BASE/100ML (EQ 20MG BASE/ML) | SOLUTION;INTRAVENOUS | CEFAZOLIN IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | 07-Aug-15 | RX |
GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG/5ML;2.5MG/5ML;30MG/5ML | SOLUTION;ORAL | HYCOFENIX | MISSION PHARMACAL CO | NDA | 14-May-15 | RX |
GLUCAGON HYDROCHLORIDE | EQ 1MG BASE/VIAL | POWDER;INTRAMUSCULAR, INTRAVENOUS | GLUCAGON | FRESENIUS KABI USA LLC | NDA | 08-May-15 | RX |
AMMONIA N-13 | 48.75mCi-487.5mCi/13ML (3.75-37.5mCi/ML) | INJECTABLE;INTRAVENOUS | AMMONIA N 13 | BIOMEDICAL RESEARCH FOUNDATION NORTHWEST LOUISANA | ANDA | 01-May-15 | RX |
MEROPENEM | 500MG/VIAL | POWDER;IV (INFUSION) | MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | B BRAUN MEDICAL INC | NDA | 30-Apr-15 | RX |
ARIPIPRAZOLE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | ARIPIPRAZOLE | ALEMBIC PHARMACEUTICALS LTD | ANDA | 28-Apr-15 | RX |
AMMONIA N-13 | 18.8mCi-188mCi/5ML (3.75-37.5mCi/ML) | INJECTABLE;INTRAVENOUS | AMMONIA N 13 | IBA MOLECULAR NORTH AMERICA INC | ANDA | 22-Apr-15 | RX |
MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML) | SOLUTION;IV (INFUSION) | MOXIFLOXACIN HYDROCHLORIDE | FRESENIUS KABI USA LLC | NDA | 03-Apr-15 | RX |
IOHEXOL | 9.7GM/BOT | FOR SOLUTION;ORAL | ORALTAG | INTERPHARMA PRAHA AS | NDA | 26-Mar-15 | RX |
MOLINDONE HYDROCHLORIDE | 5MG | TABLET;ORAL | MOLINDONE HYDROCHLORIDE | COREPHARMA LLC | ANDA | 20-Mar-15 | RX |
CHOLIC ACID | 50MG | CAPSULE;ORAL | CHOLBAM | RETROPHIN INC | NDA | 17-Mar-15 | RX |
METAXALONE | 400MG | TABLET;ORAL | METAXALONE | IMPAX LABORATORIES INC | ANDA | 27-Feb-15 | RX |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 3.68GM/1000ML; 3.05GM/1000ML; 0.314GM/1000ML ;3.09GM/1000ML; 6.34GM/1000ML; 0.187GM/1000ML (5000ML) | INJECTABLE;INJECTION | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | 13-Jan-15 | RX |
CARBIDOPA; LEVODOPA | 4.63MG/ML;20MG/ML | SUSPENSION;ENTERAL | DUOPA | ABBVIE INC | NDA | 09-Jan-15 | RX |
POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | POTASSIUM CHLORIDE | LEHIGH VALLEY TECHNOLOGIES INC | NDA | 22-Dec-14 | RX |
ARGATROBAN | 250MG/250ML (1MG/ML) | INJECTABLE;IV (INFUSION) | ARGATROBAN IN 0.9% SODIUM CHLORIDE | TEVA PHARMACEUTICALS USA | NDA | 15-Dec-14 | RX |
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | 320.5MG;30MG;16MG | CAPSULE;ORAL | TREZIX | WRASER PHARMACEUTICALS LLC | ANDA | 26-Nov-14 | RX |
SODIUM FLUORIDE F-18 | 20-600mCi/ML | INJECTABLE;INTRAVENOUS | SODIUM FLUORIDE F-18 | THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | ANDA | 19-Nov-14 | RX |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL | INJECTABLE;IV (INFUSION) | PIPERACILLIN AND TAZOBACTAM | SANDOZ INC | ANDA | 29-Oct-14 | RX |
SOTALOL HYDROCHLORIDE | 5MG/ML (5MG/ML) | SOLUTION;ORAL | SOTYLIZE | ARBOR PHARMACEUTICALS LLC | NDA | 22-Oct-14 | RX |
BUDESONIDE | 2MG/ACTUATION | AEROSOL, FOAM;RECTAL | UCERIS | VALEANT PHARMACEUTICALS INTERNATIONAL | NDA | 07-Oct-14 | RX |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 2.4%; 20MG/100ML; 6.8GM/100ML; 68MG/100ML; 124MG/100ML; 170MG/100ML; 105MG/100ML; 3.5GM/100ML (1440ML) | EMULSION;IV (INFUSION) | PERIKABIVEN IN PLASTIC CONTAINER | FRESENIUS KABI USA LLC | NDA | 25-Aug-14 | RX |
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 5MG, N/A; N/A,210GM;N/A, 0.74GM; N/A,2.86GM; N/A, 5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | NOVEL LABORATORIES INC | ANDA | 20-Aug-14 | RX |
DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | ACTICLATE | AQUA PHARMACEUTICALS LLC | NDA | 25-Jul-14 | RX |
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | 500MG;EQ 2MG BASE | TABLET;ORAL | ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | ANDA | 07-May-14 | RX |
MERCAPTOPURINE | 20MG/ML | SUSPENSION;ORAL | PURIXAN | NOVA LABORATORIES LTD | NDA | 28-Apr-14 | RX |
CEFTRIAXONE SODIUM | EQ 100GM BASE/VIAL | INJECTABLE;INJECTION | CEFTRIAXONE | SAMSON MEDICAL TECHNOLOGIES LLC | ANDA | 25-Apr-14 | RX |
OMEGA-3-ACID ETHYL ESTERS TYPE A | 1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | OMTRYG | TRYGG PHARMA INC | NDA | 23-Apr-14 | RX |
ATAZANAVIR SULFATE | EQ 100MG BASE | CAPSULE;ORAL | ATAZANAVIR SULFATE | TEVA PHARMACEUTICALS USA | ANDA | 22-Apr-14 | RX |
MILTEFOSINE | 50MG | CAPSULE;ORAL | IMPAVIDO | KNIGHT THERAPEUTICS USA INC | NDA | 19-Mar-14 | RX |
DROXIDOPA | 100MG | CAPSULE;ORAL | NORTHERA | LUNDBECK NA LTD | NDA | 18-Feb-14 | RX |
DECITABINE | 50MG/VIAL | POWDER;INTRAVENOUS | DECITABINE | SUN PHARMA GLOBAL FZE | NDA | 28-Jan-14 | RX |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | 25MG;220MG | TABLET;ORAL | ALEVE PM | BAYER HEALTHCARE CONSUMER CARE | NDA | 17-Jan-14 | OTC |
FLUDEOXYGLUCOSE F-18 | 20-150mCi/ML | INJECTABLE;INTRAVENOUS | FLUDEOXYGLUCOSE F18 | UNIV TEXAS MD ANDERSON CANCER CENTER | ANDA | 13-Jan-14 | RX |
OLIVE OIL; SOYBEAN OIL | 16%(160GM/1000ML);4% (40GM/1000ML) | INJECTABLE;INJECTION | CLINOLIPID 20% | BAXTER HEALTHCARE CORP | NDA | 03-Oct-13 | RX |
CYCLOPHOSPHAMIDE | 25MG | CAPSULE;ORAL | CYCLOPHOSPHAMIDE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | NDA | 16-Sep-13 | RX |
GRISEOFULVIN, MICROSIZE | 250MG | TABLET;ORAL | GRISEOFULVIN | SANDOZ INC | ANDA | 07-Aug-13 | RX |
ESOMEPRAZOLE STRONTIUM | 24.65MG | CAPSULE, DELAYED RELEASE;ORAL | ESOMEPRAZOLE STRONTIUM | R2 PHARMA LLC | NDA | 06-Aug-13 | RX |
FLUDEOXYGLUCOSE F-18 | 20-240mCi/ML | INJECTABLE;INTRAVENOUS | FLUDEOXYGLUCOSE F18 | MAYO CLINIC PET RADIOCHEMISTRY FACILITY | ANDA | 05-Aug-13 | RX |
SODIUM FLUORIDE F-18 | 10-91.5mCi/ML | INJECTABLE;INTRAVENOUS | SODIUM FLUORIDE F-18 | MAYO CLINIC PET RADIOCHEMISTRY FACILITY | ANDA | 28-Jun-13 | RX |
NIMODIPINE | 60MG/20ML | SOLUTION;ORAL | NYMALIZE | ARBOR PHARMACEUTICALS LLC | NDA | 10-May-13 | RX |
RABEPRAZOLE SODIUM | 5MG | CAPSULE, DELAYED RELEASE;ORAL | ACIPHEX SPRINKLE | FSC THERAPEUTICS LLC | NDA | 26-Mar-13 | RX |
GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | DOTAREM | GUERBET LLC | NDA | 20-Mar-13 | RX |
MECAMYLAMINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | MECAMYLAMINE HYDROCHLORIDE | NEXGEN PHARMA INC | ANDA | 19-Mar-13 | RX |
ZOLEDRONIC ACID | EQ 4MG BASE/VIAL | INJECTABLE;IV (INFUSION) | ZOLEDRONIC ACID | SUN PHARMA GLOBAL FZE | ANDA | 04-Mar-13 | RX |
CLOZAPINE | 50MG/ML | SUSPENSION;ORAL | VERSACLOZ | JAZZ PHARMACEUTICALS INTERNATIONAL III | NDA | 06-Feb-13 | RX |
CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | ONFI | LUNDBECK PHARMACEUTICALS LLC | NDA | 14-Dec-12 | RX |
CYSTEAMINE HYDROCHLORIDE | EQ 0.44% BASE | SOLUTION/DROPS;OPHTHALMIC | CYSTARAN | LEADIANT BIOSCIENCES INC | NDA | 02-Oct-12 | RX |
SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | REVATIO | PFIZER INC | NDA | 30-Aug-12 | RX |
DIDANOSINE | 100MG | TABLET, FOR SUSPENSION;ORAL | DIDANOSINE | AUROBINDO PHARMA LTD | ANDA | 14-Aug-12 | RX |
CEFIXIME | 400MG | CAPSULE;ORAL | SUPRAX | LUPIN LTD | NDA | 01-Jun-12 | RX |
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 30,250USP UNITS;8,000USP UNITS;28,750USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | PERTZYE | DIGESTIVE CARE INC | NDA | 17-May-12 | RX |
AMINO ACIDS | 15%(150GM/1000ML) | INJECTABLE;INJECTION | AMINO ACIDS | B BRAUN MEDICAL INC | ANDA | 13-Apr-12 | RX |
GLYCOPYRROLATE | 1.5MG | TABLET;ORAL | GLYCOPYRROLATE | NEXGEN PHARMA INC | ANDA | 12-Mar-12 | RX |
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 27,600USP UNITS; 13,800USP UNITS; 27,600USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | ULTRESA | FOREST LABORATORIES INC | NDA | 01-Mar-12 | RX |
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 39,150USP UNITS;10,440USP UNITS;39,150USP UNITS | TABLET;ORAL | VIOKACE | FOREST LABORATORIES INC | NDA | 01-Mar-12 | RX |
CARBOPLATIN | 1GM/100ML (10MG/ML) | INJECTABLE;IV (INFUSION) | CARBOPLATIN | MYLAN LABORATORIES LTD | ANDA | 23-Nov-11 | RX |
DEXTROAMPHETAMINE SULFATE | 2.5MG | TABLET;ORAL | DEXTROAMPHETAMINE SULFATE | MIKART INC | ANDA | 25-Oct-11 | RX |
FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | FLUOXETINE HYDROCHLORIDE | ALVOGEN GROUP HOLDINGS 3 LLC | NDA | 06-Oct-11 | RX |
PURIFIED WATER | 98.30% | SOLUTION;OPHTHALMIC | PUR-WASH | NIAGARA PHARMACEUTICALS INC | NDA | 01-Sep-11 | OTC |
NITROGLYCERIN | 0.40% | OINTMENT;INTRA-ANAL | RECTIV | FOREST LABORATORIES INC | NDA | 21-Jun-11 | RX |
ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG | TABLET;ORAL | NORGESTIMATE AND ETHINYL ESTRADIOL | GLENMARK GENERICS LTD | ANDA | 17-Jun-11 | RX |
CEFTAZIDIME | EQ 1GM BASE | INJECTABLE;INJECTION | CEFTAZIDIME IN DEXTROSE CONTAINER | B BRAUN MEDICAL INC | NDA | 13-Jun-11 | RX |
EZOGABINE | 50MG | TABLET;ORAL | POTIGA | GLAXOSMITHKLINE | NDA | 10-Jun-11 | RX |
DOCETAXEL | 20MG/VIAL | INJECTABLE;INJECTION | DOCEFREZ | SUN PHARMA GLOBAL FZE | NDA | 03-May-11 | RX |
METHYLERGONOVINE MALEATE | 0.2MG | TABLET;ORAL | METHYLERGONOVINE MALEATE | NOVEL LABORATORIES INC | ANDA | 02-May-11 | RX |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;10MG | TABLET;ORAL | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | INVAGEN PHARMACEUTICALS INC | ANDA | 20-Apr-11 | RX |
LOTEPREDNOL ETABONATE | 0.50% | OINTMENT;OPHTHALMIC | LOTEMAX | BAUSCH AND LOMB INC | NDA | 15-Apr-11 | RX |
AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE | 500MG, N/A, N/A; N/A, 500MG, N/A; N/A, N/A, 20MG | CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL | OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN | GASTROENTERO LOGIC LLC | NDA | 08-Feb-11 | RX |
HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION;INTRAMUSCULAR | MAKENA | AMAG PHARMA USA INC | NDA | 03-Feb-11 | RX |
IOFLUPANE I-123 | 5mCi/2.5ML (2mCi/ML) | SOLUTION;INTRAVENOUS | DATSCAN | GE HEALTHCARE INC | NDA | 14-Jan-11 | RX |
CEFIXIME | 100MG | TABLET, CHEWABLE;ORAL | SUPRAX | LUPIN LTD | ANDA | 25-Oct-10 | RX |
PREDNISOLONE SODIUM PHOSPHATE | EQ 25MG BASE/5ML | SOLUTION;ORAL | PREDNISOLONE SODIUM PHOSPHATE | MISSION PHARMACAL CO | ANDA | 13-Sep-10 | RX |
PILOCARPINE HYDROCHLORIDE | 1% | SOLUTION;OPHTHALMIC | ISOPTO CARPINE | NOVARTIS PHARMACEUTICALS CORP | NDA | 22-Jun-10 | RX |
CHLORZOXAZONE | 375MG | TABLET;ORAL | CHLORZOXAZONE | MIKART INC | ANDA | 01-Jun-10 | RX |
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 17,500USP/ UNITS;4,200USP/ UNITS;10,000USP/ UNITS | CAPSULE, DELAYED RELEASE;ORAL | PANCREAZE | JANSSEN PHARMACEUTICALS INC | NDA | 12-Apr-10 | RX |
POLIDOCANOL | 10MG/2ML (5MG/ML) | SOLUTION;INTRAVENOUS | ASCLERA | CHEMISCHE FABRIK KREUSSLER & CO. GMBH | NDA | 30-Mar-10 | RX |
CALCIPOTRIENE | 0.01% | OINTMENT;TOPICAL | CALCIPOTRIENE | GLENMARK GENERICS INC USA | ANDA | 24-Mar-10 | RX |
CARGLUMIC ACID | 200MG | TABLET;ORAL | CARBAGLU | ORPHAN EUROPE | NDA | 18-Mar-10 | RX |
INDOMETHACIN | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | INDOMETHACIN | FRESENIUS KABI USA LLC | NDA | 17-Mar-10 | RX |
TRIPTORELIN PAMOATE | EQ 22.5MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR | TRELSTAR | ALLERGAN SALES LLC | NDA | 10-Mar-10 | RX |
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE;INJECTION | ORABLOC | PIERREL S.P.A. | NDA | 26-Feb-10 | RX |
VELAGLUCERASE ALFA | 400 UNITS/VIAL | INJECTABLE;IV (INFUSION) | VPRIV | SHIRE HUMAN GENETIC THERAPIES INC | NDA | 26-Feb-10 | RX |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG/15ML;10MG/15ML | SOLUTION;ORAL | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | MIKART INC | ANDA | 25-Feb-10 | RX |
NIZATIDINE | 15MG/ML | SOLUTION;ORAL | NIZATIDINE | AMNEAL PHARMACEUTICALS | ANDA | 18-Nov-09 | RX |
CHENODIOL | 250MG | TABLET;ORAL | CHENODIOL | NEXGEN PHARMA INC | ANDA | 22-Oct-09 | RX |
GANCICLOVIR | 0.15% | GEL;OPHTHALMIC | ZIRGAN | BAUSCH AND LOMB INC | NDA | 15-Sep-09 | RX |
VIGABATRIN | 500MG | TABLET;ORAL | SABRIL | LUNDBECK PHARMACEUTICALS LLC | NDA | 21-Aug-09 | RX |
TECHNETIUM TC-99M SESTAMIBI KIT | 10-30mCi | INJECTABLE;INJECTION | TECHNETIUM TC 99M SESTAMIBI | PHARMALUCENCE INC | ANDA | 10-Jul-09 | RX |
SOTALOL HYDROCHLORIDE | 150MG/10ML (15MG/ML) | SOLUTION;INTRAVENOUS | SOTALOL HYDROCHLORIDE | ALTATHERA PHARMACEUTICALS LLC | NDA | 02-Jul-09 | RX |
OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE;ORAL | OMEPRAZOLE MAGNESIUM | DR REDDYS LABORATORIES LTD | ANDA | 05-Jun-09 | OTC |
CIPROFLOXACIN HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS;OTIC | CETRAXAL | WRASER PHARMACEUTICALS LLC | NDA | 01-May-09 | RX |
ARTEMETHER; LUMEFANTRINE | 20MG;120MG | TABLET;ORAL | COARTEM | NOVARTIS PHARMACEUTICALS CORP | NDA | 07-Apr-09 | RX |
TRYPAN BLUE | 0.15% | SOLUTION;OPHTHALMIC | MEMBRANEBLUE | DORC INTERNATIONAL BV | NDA | 20-Feb-09 | RX |
GALANTAMINE HYDROBROMIDE | 4MG/ML | SOLUTION;ORAL | GALANTAMINE HYDROBROMIDE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | ANDA | 30-Jan-09 | RX |
CALCITRIOL | 3MCG/GM | OINTMENT;TOPICAL | VECTICAL | GALDERMA LABORATORIES LP | NDA | 23-Jan-09 | RX |
IOBENGUANE SULFATE I-123 | 10mCi/5ML (2mCi/ML) | SOLUTION;INTRAVENOUS | ADREVIEW | GE HEALTHCARE | NDA | 19-Sep-08 | RX |
POTASSIUM CHLORIDE; SODIUM CHLORIDE | 149MG/100ML;450MG/100ML | INJECTABLE;INJECTION | POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | ICU MEDICAL INC | ANDA | 10-Sep-08 | RX |
CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/50ML (EQ 20MG BASE/ML) | INJECTABLE;INJECTION | CEFEPIME IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | 05-Aug-08 | RX |
NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE;ORAL | NISOLDIPINE | MYLAN PHARMACEUTICALS INC | ANDA | 25-Jul-08 | RX |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG/15ML;10MG/15ML | SOLUTION;ORAL | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | PHARMACEUTICAL ASSOC INC | ANDA | 18-Apr-08 | RX |
MORPHINE SULFATE | 15MG | TABLET;ORAL | MORPHINE SULFATE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | NDA | 17-Mar-08 | RX |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | TABLET;ORAL-21 | TRI-LEGEST 21 | BARR LABORATORIES INC | ANDA | 26-Oct-07 | RX |
TERBINAFINE HYDROCHLORIDE | EQ 125MG BASE/PACKET | GRANULE;ORAL | LAMISIL | NOVARTIS PHARMACEUTICALS CORP | NDA | 28-Sep-07 | RX |
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX | EQ 8MG MALEATE;EQ 10MG BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | TUSSICAPS | ECR PHARMA | ANDA | 24-Sep-07 | RX |
ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL;TRANSDERMAL | DIVIGEL | VERTICAL PHARMACEUTICALS LLC | NDA | 04-Jun-07 | RX |
LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | CLARITIN REDITABS | BAYER HEALTHCARE LLC | NDA | 12-Dec-06 | OTC |
CEFAZOLIN SODIUM | EQ 100GM BASE/VIAL | INJECTABLE;INJECTION | CEFAZOLIN SODIUM | SAMSON MEDICAL TECHNOLOGIES LLC | ANDA | 29-Nov-06 | RX |
NITROGLYCERIN | 0.4MG/SPRAY | AEROSOL, METERED;SUBLINGUAL | NITROMIST | MIST PHARMACEUTICALS LLC | NDA | 02-Nov-06 | RX |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 5.15GM/1000ML; N/A/1000ML; 5.4GM/1000ML; 2.03GM/1000ML; N/A/1000ML; 3.09GM/1000ML; 6.46GM/1000ML (5000ML) | INJECTABLE;INJECTION | PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | 25-Oct-06 | RX |
AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE | 2%;2%;10%;2% | CREAM;TOPICAL | ANTHELIOS 20 | LOREAL USA PRODUCTS INC | NDA | 05-Oct-06 | OTC |
AVOBENZONE; ECAMSULE; OCTOCRYLENE | 2%;3%;10% | CREAM;TOPICAL | CAPITAL SOLEIL 15 | LOREAL USA PRODUCTS INC | NDA | 02-Oct-06 | OTC |
IODINE POVACRYLEX; ISOPROPYL ALCOHOL | EQ 0.7% IODINE;74% (6ML) | SPONGE;TOPICAL | DURAPREP | 3M HEALTH CARE INC | NDA | 29-Sep-06 | OTC |
ATROPINE; PRALIDOXIME CHLORIDE | 2.1MG/0.7ML;600MG/2ML | INJECTABLE;INTRAMUSCULAR | DUODOTE | MERIDIAN MEDICAL TECHNOLOGIES INC | NDA | 28-Sep-06 | RX |
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 220MG BASE;120MG | TABLET, EXTENDED RELEASE;ORAL | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | DR REDDYS LABORATORIES INC | ANDA | 27-Sep-06 | OTC |
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE | 12.5MG;EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | DUTOPROL | CONCORDIA PHARMACEUTICALS INC | NDA | 28-Aug-06 | RX |
LORATADINE | 5MG | TABLET, CHEWABLE;ORAL | CHILDREN\'S CLARITIN | BAYER HEALTHCARE LLC | NDA | 23-Aug-06 | OTC |
SODIUM CHLORIDE | 405MG/50ML (9MG/ML) | INJECTABLE;INJECTION | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | LIEBEL-FLARSHEIM CO LLC | NDA | 27-Jul-06 | RX |
AVOBENZONE; ECAMSULE; OCTOCRYLENE | 2%;2%;10% | CREAM;TOPICAL | ANTHELIOS SX | LOREAL USA PRODUCTS INC | NDA | 21-Jul-06 | OTC |
SELEGILINE HYDROCHLORIDE | 1.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | ZELAPAR | VALEANT PHARMACEUTICALS INTERNATIONAL | NDA | 14-Jun-06 | RX |
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML) | INJECTABLE;INJECTION | SEPTOCAINE | DEPROCO INC | NDA | 30-Mar-06 | RX |
NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE;ORAL | NAPROXEN SODIUM | BIONPHARMA INC | NDA | 17-Feb-06 | OTC |
FLUNISOLIDE | 0.078MG/INH | AEROSOL, METERED;INHALATION | AEROSPAN HFA | MYLAN SPECIALTY LP | NDA | 27-Jan-06 | RX |
FENOFIBRATE | 50MG | CAPSULE;ORAL | LIPOFEN | CIPHER PHARMACEUTICALS INC | NDA | 11-Jan-06 | RX |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 300MG;2.5MG | TABLET;ORAL | OXYCODONE AND ACETAMINOPHEN | MIKART INC | ANDA | 30-Dec-05 | RX |
CARBAMAZEPINE | 100MG | TABLET;ORAL | CARBAMAZEPINE | TORRENT PHARMACEUTICALS LTD | ANDA | 07-Dec-05 | RX |
LORATADINE | 1MG/ML | SUSPENSION;ORAL | LORATADINE | TARO PHARMACEUTICALS USA INC | NDA | 04-Oct-05 | OTC |
CEFTRIAXONE SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | CEFTRIAXONE IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | ANDA | 23-Aug-05 | RX |
LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE;ORAL | LOPERAMIDE HYDROCHLORIDE | BIONPHARMA INC | NDA | 04-Aug-05 | OTC |
DOXYCYCLINE HYCLATE | EQ 20MG BASE | CAPSULE;ORAL | DOXYCYCLINE HYCLATE | HIKMA INTERNATIONAL PHARMACEUTICALS LLC | ANDA | 13-May-05 | RX |
ESTRADIOL; NORGESTIMATE | 1MG,1MG;N/A,0.09MG | TABLET;ORAL | ESTRADIOL AND NORGESTIMATE | BARR LABORATORIES INC | ANDA | 29-Apr-05 | RX |
ENTECAVIR | 0.05MG/ML | SOLUTION;ORAL | BARACLUDE | BRISTOL MYERS SQUIBB | NDA | 29-Mar-05 | RX |
DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | CARDURA XL | PFIZER INC | NDA | 22-Feb-05 | RX |
SAQUINAVIR MESYLATE | EQ 500MG BASE | TABLET;ORAL | INVIRASE | HOFFMANN-LA ROCHE INC | NDA | 17-Dec-04 | RX |
TRYPAN BLUE | 0.06% | SOLUTION;OPHTHALMIC | VISIONBLUE | DORC INTERNATIONAL BV | NDA | 16-Dec-04 | RX |
LOTEPREDNOL ETABONATE; TOBRAMYCIN | 0.5%;0.3% | SUSPENSION/DROPS;OPHTHALMIC | ZYLET | BAUSCH AND LOMB INC | NDA | 14-Dec-04 | RX |
GADOBENATE DIMEGLUMINE | 2.645GM/5ML (529MG/ML) | INJECTABLE;INTRAVENOUS | MULTIHANCE | BRACCO DIAGNOSTICS INC | NDA | 23-Nov-04 | RX |
GADOBENATE DIMEGLUMINE | 26.45GM/50ML (529MG/ML) | INJECTABLE;INTRAVENOUS | MULTIHANCE MULTIPACK | BRACCO DIAGNOSTICS INC | NDA | 23-Nov-04 | RX |
SODIUM TETRADECYL SULFATE | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | SOTRADECOL | MYLAN INSTITUTIONAL LLC | ANDA | 12-Nov-04 | RX |
MENOTROPINS (FSH;LH) | 75 IU/VIAL;75 IU/VIAL | INJECTABLE;SUBCUTANEOUS | MENOPUR | FERRING PHARMACEUTICALS INC | NDA | 29-Oct-04 | RX |
DIGOXIN | 0.05MG/ML | ELIXIR;ORAL | DIGOXIN | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | NDA | 26-Aug-04 | RX |
PENTETATE CALCIUM TRISODIUM | EQ 1GM BASE/5ML (EQ 200MG BASE/ML) | SOLUTION;INHALATION, INTRAVENOUS | PENTETATE CALCIUM TRISODIUM | HAMELN PHARMA PLUS GMBH | NDA | 11-Aug-04 | RX |
PENTETATE ZINC TRISODIUM | EQ 1GM BASE/5ML (EQ 200MG BASE/ML) | SOLUTION;INHALATION, INTRAVENOUS | PENTETATE ZINC TRISODIUM | HAMELN PHARMA PLUS GMBH | NDA | 11-Aug-04 | RX |
PIPERACILLIN SODIUM | EQ 40GM BASE/VIAL | INJECTABLE;INJECTION | PIPERACILLIN | ISTITUTO BIOCHIMICO ITALIANO SPA | ANDA | 12-Jul-04 | RX |
GLUTAMINE | 5GM/PACKET | FOR SOLUTION;ORAL | NUTRESTORE | EMMAUS MEDICAL INC | NDA | 10-Jun-04 | RX |
SECRETIN SYNTHETIC HUMAN | 16MCG/VIAL | FOR SOLUTION;INTRAVENOUS | CHIRHOSTIM | CHIRHOCLIN INC | NDA | 09-Apr-04 | RX |
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1MG/5ML;100MG/5ML;15MG/5ML | SUSPENSION;ORAL | CHILDREN\'S ADVIL ALLERGY SINUS | PFIZER INC | NDA | 24-Feb-04 | OTC |
CEFIXIME | 400MG | TABLET;ORAL | SUPRAX | LUPIN PHARMACEUTICALS INC | ANDA | 12-Feb-04 | RX |
TALC | 5GM/BOT | POWDER;INTRAPLEURAL | TALC | LYMOL MEDICAL CORP | NDA | 15-Dec-03 | RX |
SERTACONAZOLE NITRATE | 2% | CREAM;TOPICAL | ERTACZO | VALEANT PHARMACEUTICALS LUXEMBOURG SARL | NDA | 10-Dec-03 | RX |
ESTRADIOL; LEVONORGESTREL | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | CLIMARA PRO | BAYER HEALTHCARE PHARMACEUTICALS INC | NDA | 21-Nov-03 | RX |
ESTRADIOL HEMIHYDRATE | 0.25% | EMULSION;TOPICAL | ESTRASORB | EXELTIS USA INC | NDA | 09-Oct-03 | RX |
FERRIC HEXACYANOFERRATE(II) | 500MG | CAPSULE;ORAL | RADIOGARDASE (PRUSSIAN BLUE) | HEYL CHEMISCH PHARMAZEUTISHE FABRIK | NDA | 02-Oct-03 | RX |
FAMOTIDINE | 10MG | TABLET, CHEWABLE;ORAL | FAMOTIDINE | L PERRIGO CO | ANDA | 22-Aug-03 | OTC |
MIGLUSTAT | 100MG | CAPSULE;ORAL | ZAVESCA | ACTELION PHARMACEUTICALS LTD | NDA | 31-Jul-03 | RX |
NELFINAVIR MESYLATE | EQ 625MG BASE | TABLET;ORAL | VIRACEPT | AGOURON PHARMACEUTICALS LLC | NDA | 30-Apr-03 | RX |
DESIRUDIN RECOMBINANT | 15MG/VIAL | INJECTABLE;SUBCUTANEOUS | IPRIVASK | VALEANT PHARMACEUTICALS NORTH AMERICA LLC | NDA | 04-Apr-03 | RX |
ESTRADIOL ACETATE | EQ 0.05MG BASE/24HR | INSERT, EXTENDED RELEASE;VAGINAL | FEMRING | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD | NDA | 20-Mar-03 | RX |
ENFUVIRTIDE | 90MG/VIAL | INJECTABLE;SUBCUTANEOUS | FUZEON | HOFFMANN LA ROCHE INC | NDA | 13-Mar-03 | RX |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG/15ML;50MG/15ML;40MG/15ML | SOLUTION;ORAL | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | MIKART INC | ANDA | 31-Jan-03 | RX |
ACYCLOVIR | 5% | CREAM;TOPICAL | ZOVIRAX | VALEANT INTERNATIONAL BERMUDA | NDA | 30-Dec-02 | RX |
CITRIC ACID; UREA C-13 | N/A,4GM;75MG,N/A | FOR SOLUTION, TABLET, FOR SOLUTION;ORAL | IDKIT:HP | EXALENZ BIOSCIENCE LTD | NDA | 17-Dec-02 | RX |
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE;ORAL | ADVIL COLD AND SINUS | PFIZER INC | NDA | 30-May-02 | OTC |
UROFOLLITROPIN | 75 IU/VIAL | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | BRAVELLE | FERRING PHARMACEUTICALS INC | NDA | 06-May-02 | RX |
HYDROCORTISONE ACETATE | 2% | CREAM;TOPICAL | MICORT-HC | SEBELA IRELAND LTD | ANDA | 29-Mar-02 | RX |
NALTREXONE HYDROCHLORIDE | 25MG | TABLET;ORAL | NALTREXONE HYDROCHLORIDE | MALLINCKRODT INC | ANDA | 22-Mar-02 | RX |
MESNA | 400MG | TABLET;ORAL | MESNEX | BAXTER HEALTHCARE CORP | NDA | 21-Mar-02 | RX |
NITISINONE | 2MG | CAPSULE;ORAL | ORFADIN | SWEDISH ORPHAN BIOVITRUM AB PUBL | NDA | 18-Jan-02 | RX |
BOSENTAN | 62.5MG | TABLET;ORAL | TRACLEER | ACTELION PHARMACEUTICALS LTD | NDA | 20-Nov-01 | RX |
DAUNORUBICIN HYDROCHLORIDE | EQ 5MG BASE/VIAL | INJECTABLE;INJECTION | DAUNORUBICIN HYDROCHLORIDE | FRESENIUS KABI USA LLC | ANDA | 20-Nov-01 | RX |
NESIRITIDE RECOMBINANT | 1.5MG/VIAL | FOR SOLUTION;INTRAVENOUS | NATRECOR | SCIOS LLC | NDA | 10-Aug-01 | RX |
ATROPINE SULFATE | 0.1MG/ML | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | ATROPINE SULFATE ANSYR PLASTIC SYRINGE | HOSPIRA INC | NDA | 09-Jul-01 | RX |
TRIPTORELIN PAMOATE | EQ 11.25MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR | TRELSTAR | ALLERGAN SALES LLC | NDA | 29-Jun-01 | RX |
METHOTREXATE SODIUM | EQ 5MG BASE | TABLET;ORAL | TREXALL | BARR LABORATORIES INC | ANDA | 21-Mar-01 | RX |
CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | B BRAUN MEDICAL INC | NDA | 21-Feb-01 | RX |
IRON SUCROSE | EQ 100MG BASE/5ML (EQ 20MG BASE/ML) | INJECTABLE;INTRAVENOUS | VENOFER | LUITPOLD PHARMACEUTICALS INC | NDA | 06-Nov-00 | RX |
TAZAROTENE | 0.05% | CREAM;TOPICAL | TAZORAC | ALLERGAN INC | NDA | 29-Sep-00 | RX |
MIFEPRISTONE | 200MG | TABLET;ORAL | MIFEPREX | DANCO LABORATORIES LLC | NDA | 28-Sep-00 | RX |
EFLORNITHINE HYDROCHLORIDE | 13.90% | CREAM;TOPICAL | VANIQA | SKINMEDICA INC | NDA | 27-Jul-00 | RX |
DOCOSANOL | 10% | CREAM;TOPICAL | ABREVA | GLAXOSMITHKLINE | NDA | 25-Jul-00 | OTC |
TRIPTORELIN PAMOATE | EQ 3.75MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR | TRELSTAR | ALLERGAN SALES LLC | NDA | 15-Jun-00 | RX |
VERTEPORFIN | 15MG/VIAL | INJECTABLE;INJECTION | VISUDYNE | VALEANT PHARMACEUTICALS LUXEMBOURG SARL | NDA | 12-Apr-00 | RX |
LEVORPHANOL TARTRATE | 2MG | TABLET;ORAL | LEVORPHANOL TARTRATE | SENTYNL THERAPEUTICS INC | ANDA | 31-Mar-00 | RX |
CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER | HOSPIRA INC | NDA | 28-Jan-00 | RX |
GADOVERSETAMIDE | 16.545GM/50ML (330.9MG/ML) | INJECTABLE;INJECTION | OPTIMARK | LIEBEL-FLARSHEIM CO LLC | NDA | 08-Dec-99 | RX |
GADOVERSETAMIDE | 1654.5MG/5ML (330.9MG/ML) | INJECTABLE;INJECTION | OPTIMARK | LIEBEL-FLARSHEIM CO LLC | NDA | 08-Dec-99 | RX |
GADOVERSETAMIDE | 9927MG/30ML (330.9MG/ML) | INJECTABLE;INJECTION | OPTIMARK IN PLASTIC CONTAINER | LIEBEL-FLARSHEIM CO LLC | NDA | 08-Dec-99 | RX |
PORACTANT ALFA | 80MG/ML | SUSPENSION;INTRATRACHEAL | CUROSURF | CHIESI USA INC | NDA | 18-Nov-99 | RX |
DALFOPRISTIN; QUINUPRISTIN | 350MG/VIAL;150MG/VIAL | INJECTABLE;IV (INFUSION) | SYNERCID | KING PHARMACEUTICALS INC | NDA | 21-Sep-99 | RX |
SIROLIMUS | 1MG/ML | SOLUTION;ORAL | RAPAMUNE | PF PRISM CV | NDA | 15-Sep-99 | RX |
ZANAMIVIR | 5MG | POWDER;INHALATION | RELENZA | GLAXOSMITHKLINE | NDA | 26-Jul-99 | RX |
CYTARABINE | 10MG/ML | INJECTABLE, LIPOSOMAL;INJECTION | DEPOCYT | PACIRA PHARMACEUTICALS INC | NDA | 01-Apr-99 | RX |
LEUCOVORIN CALCIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | LEUCOVORIN CALCIUM PRESERVATIVE FREE | FRESENIUS KABI USA LLC | ANDA | 26-Feb-99 | RX |
METHOXSALEN | 0.02MG/ML | INJECTABLE;INJECTION | UVADEX | MALLINCKRODT HOSPITAL PRODUCTS IP LTD | NDA | 25-Feb-99 | RX |
THYROTROPIN ALFA | 1.1MG/VIAL | INJECTABLE;INJECTION | THYROGEN | GENZYME CORP | NDA | 30-Nov-98 | RX |
VALRUBICIN | 40MG/ML | SOLUTION;INTRAVESICAL | VALSTAR PRESERVATIVE FREE | ENDO PHARMACEUTICAL SOLUTIONS INC | NDA | 25-Sep-98 | RX |
GLUCAGON RECOMBINANT | 1MG/VIAL | INJECTABLE;INJECTION | GLUCAGON | ELI LILLY AND CO | NDA | 11-Sep-98 | RX |
DOXYCYCLINE HYCLATE | 50MG | SYSTEM, EXTENDED RELEASE;PERIODONTAL | ATRIDOX | TOLMAR INC | NDA | 03-Sep-98 | RX |
AMINO ACIDS | 20% (20GM/100ML) | INJECTABLE;INJECTION | PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER | BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV | NDA | 26-Aug-98 | RX |
ESTRADIOL; NORETHINDRONE ACETATE | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | COMBIPATCH | NOVEN PHARMACEUTICALS INC | NDA | 07-Aug-98 | RX |
CALFACTANT | 35MG/ML | SUSPENSION;INTRATRACHEAL | INFASURF PRESERVATIVE FREE | ONY INC | NDA | 01-Jul-98 | RX |
GLUCAGON HYDROCHLORIDE RECOMBINANT | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | GLUCAGEN | NOVO NORDISK PHARMACEUTICALS INC | NDA | 22-Jun-98 | RX |
RIFAPENTINE | 150MG | TABLET;ORAL | PRIFTIN | SANOFI AVENTIS US LLC | NDA | 22-Jun-98 | RX |
CHLORHEXIDINE GLUCONATE | 2.5MG | TABLET;DENTAL | PERIOCHIP | DEXCEL PHARMA TECHNOLOGIES LTD | NDA | 15-May-98 | RX |
BRINZOLAMIDE | 1% | SUSPENSION/DROPS;OPHTHALMIC | AZOPT | NOVARTIS PHARMACEUTICALS CORP | NDA | 01-Apr-98 | RX |
CIPROFLOXACIN HYDROCHLORIDE | EQ 0.3% BASE | OINTMENT;OPHTHALMIC | CILOXAN | NOVARTIS PHARMACEUTICALS CORP | NDA | 30-Mar-98 | RX |
LOTEPREDNOL ETABONATE | 0.20% | SUSPENSION/DROPS;OPHTHALMIC | ALREX | BAUSCH AND LOMB INC | NDA | 09-Mar-98 | RX |
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE | EQ 0.2% BASE;1% | SUSPENSION/DROPS;OTIC | CIPRO HC | NOVARTIS PHARMACEUTICALS CORP | NDA | 10-Feb-98 | RX |
IBUPROFEN | 100MG/2.5ML | SUSPENSION/DROPS;ORAL | PEDIATRIC ADVIL | PFIZER INC | NDA | 30-Jan-98 | OTC |
EMEDASTINE DIFUMARATE | 0.05% | SOLUTION/DROPS;OPHTHALMIC | EMADINE | NOVARTIS PHARMACEUTICALS CORP | NDA | 29-Dec-97 | RX |
TALC | 400MG/SPRAY | AEROSOL, METERED;INTRAPLEURAL | SCLEROSOL | LYMOL MEDICAL CORP | NDA | 24-Dec-97 | RX |
LACTULOSE | 10GM/PACKET | FOR SOLUTION;ORAL | LACTULOSE | CUMBERLAND PHARMACEUTICALS INC | ANDA | 10-Dec-97 | RX |
DIHYDROERGOTAMINE MESYLATE | 0.5MG/INH | SPRAY, METERED;NASAL | MIGRANAL | VALEANT PHARMACEUTICALS INTERNATIONAL | NDA | 08-Dec-97 | RX |
KETOCONAZOLE | 1% | SHAMPOO;TOPICAL | NIZORAL A-D | JOHNSON AND JOHNSON HEALTHCARE PRODUCTS DIV MCNEIL-PPC INC | NDA | 10-Oct-97 | OTC |
DIGOXIN | 0.0625MG | TABLET;ORAL | LANOXIN | CONCORDIA PHARMACEUTICALS INC | NDA | 30-Sep-97 | RX |
METRONIDAZOLE | 1% | CREAM;TOPICAL | NORITATE | VALEANT PHARMACEUTICALS NORTH AMERICA LLC | NDA | 26-Sep-97 | RX |
CHLORHEXIDINE GLUCONATE | 0.75% | SOLUTION;TOPICAL | DYNA-HEX | BAJAJ MECICAL LLC | NDA | 11-Sep-97 | OTC |
DOLASETRON MESYLATE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | ANZEMET | US PHARMACEUTICAL HOLDINGS II LLC | NDA | 11-Sep-97 | RX |
DOLASETRON MESYLATE | 50MG | TABLET;ORAL | ANZEMET | US PHARMACEUTICAL HOLDINGS II LLC | NDA | 11-Sep-97 | RX |
PROGESTERONE | 4% | GEL;VAGINAL | CRINONE | ALLERGAN SALES LLC | NDA | 31-Jul-97 | RX |
DIAZEPAM | 2.5MG/0.5ML (5MG/ML) | GEL;RECTAL | DIASTAT | VALEANT PHARMACEUTICALS NORTH AMERICA LLC | NDA | 29-Jul-97 | RX |
SODIUM FLUORIDE; TRICLOSAN | 0.24%;0.3% | PASTE;DENTAL | COLGATE TOTAL | COLGATE PALMOLIVE | NDA | 11-Jul-97 | OTC |
TAZAROTENE | 0.05% | GEL;TOPICAL | TAZORAC | ALLERGAN INC | NDA | 13-Jun-97 | RX |
TOREMIFENE CITRATE | EQ 60MG BASE | TABLET;ORAL | FARESTON | KYOWA KIRIN INC | NDA | 29-May-97 | RX |
NICOTINE | 4MG/CARTRIDGE | INHALANT;ORAL | NICOTROL | PHARMACIA AND UPJOHN CO | NDA | 02-May-97 | RX |
SAMARIUM SM-153 LEXIDRONAM PENTASODIUM | 50mCi/ML | INJECTABLE;INJECTION | QUADRAMET | LANTHEUS MEDICAL IMAGING INC | NDA | 28-Mar-97 | RX |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 2.75%;33MG/100ML;5GM/100ML; 51MG/100ML;261MG/100ML; 217MG/100ML;112MG/100ML | INJECTABLE;INJECTION | CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | 26-Mar-97 | RX |
NELFINAVIR MESYLATE | EQ 250MG BASE | TABLET;ORAL | VIRACEPT | AGOURON PHARMACEUTICALS LLC | NDA | 14-Mar-97 | RX |
PODOFILOX | 0.50% | GEL;TOPICAL | CONDYLOX | ALLERGAN SALES LLC | NDA | 13-Mar-97 | RX |
HYDROCORTISONE PROBUTATE | 0.10% | CREAM;TOPICAL | PANDEL | FOUGERA PHARMACEUTICALS INC | NDA | 28-Feb-97 | RX |
ZINC ACETATE | EQ 25MG ZINC | CAPSULE;ORAL | GALZIN | TEVA PHARMACEUTICALS USA INC | NDA | 28-Jan-97 | RX |
FOSFOMYCIN TROMETHAMINE | EQ 3GM BASE/PACKET | FOR SUSPENSION;ORAL | MONUROL | ZAMBON SPA ITALY | NDA | 19-Dec-96 | RX |
ALPROSTADIL | 0.125MG | SUPPOSITORY;URETHRAL | MUSE | MYLAN SPECIALTY LP | NDA | 19-Nov-96 | RX |
BETAINE HYDROCHLORIDE | 1GM/SCOOPFUL | FOR SOLUTION;ORAL | CYSTADANE | RARE DISEASE THERAPEUTICS INC | NDA | 25-Oct-96 | RX |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | 0.2MG/ML;0.8MG/ML;0.3MG/ML; 0.3MG/ML;1.9MG/ML;7.3MG/ML; 0.2MG/ML | INJECTABLE;INTRATHECAL | ELLIOTTS B SOLUTION | LUKARE MEDICAL LLC | NDA | 27-Sep-96 | RX |
PENTOSAN POLYSULFATE SODIUM | 100MG | CAPSULE;ORAL | ELMIRON | JANSSEN PHARMACEUTICALS INC | NDA | 26-Sep-96 | RX |
CARMUSTINE | 7.7MG | IMPLANT;INTRACRANIAL | GLIADEL | ARBOR PHARMACEUTICALS LLC | NDA | 23-Sep-96 | RX |
BENTOQUATAM | 5% | LOTION;TOPICAL | IVY BLOCK | STANDARD HOMEOPATHIC CO | NDA | 26-Aug-96 | OTC |
CLOTRIMAZOLE | 200MG | TABLET;VAGINAL | GYNE-LOTRIMIN 3 | BAYER HEALTHCARE LLC | NDA | 29-Jul-96 | OTC |
ALBENDAZOLE | 200MG | TABLET;ORAL | ALBENZA | AMEDRA PHARMACEUTICALS LLC | NDA | 11-Jun-96 | RX |
CORTICORELIN OVINE TRIFLUTATE | EQ 0.1MG BASE/VIAL | INJECTABLE;INJECTION | ACTHREL | FERRING PHARMACEUTICALS INC | NDA | 23-May-96 | RX |
ETOPOSIDE PHOSPHATE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | ETOPOPHOS PRESERVATIVE FREE | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE | NDA | 17-May-96 | RX |
NIZATIDINE | 75MG | TABLET;ORAL | AXID AR | PFIZER INC | NDA | 09-May-96 | OTC |
ESTRADIOL | 0.0075MG/24HR | INSERT, EXTENDED RELEASE;VAGINAL | ESTRING | PHARMACIA AND UPJOHN CO | NDA | 26-Apr-96 | RX |
NICOTINE | 0.5MG/SPRAY | SPRAY, METERED;NASAL | NICOTROL | PFIZER INC | NDA | 22-Mar-96 | RX |
PORFIMER SODIUM | 75MG/VIAL | INJECTABLE;INJECTION | PHOTOFRIN | CONCORDIA LABORATORIES INC | NDA | 27-Dec-95 | RX |
SAQUINAVIR MESYLATE | EQ 200MG BASE | CAPSULE;ORAL | INVIRASE | HOFFMANN LA ROCHE INC | NDA | 06-Dec-95 | RX |
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | 0.625MG;2.5MG | TABLET;ORAL-28 | PREMPRO | WYETH PHARMACEUTICALS INC | NDA | 17-Nov-95 | RX |
MUPIROCIN CALCIUM | EQ 2% BASE | OINTMENT;NASAL | BACTROBAN | GLAXOSMITHKLINE | NDA | 18-Sep-95 | RX |
AZELAIC ACID | 20% | CREAM;TOPICAL | AZELEX | ALLERGAN INC | NDA | 13-Sep-95 | RX |
AZATHIOPRINE SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | AZATHIOPRINE SODIUM | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | ANDA | 31-Mar-95 | RX |
DINOPROSTONE | 10MG | INSERT, EXTENDED RELEASE;VAGINAL | CERVIDIL | FERRING PHARMACEUTICALS INC | NDA | 30-Mar-95 | RX |
TRIAMCINOLONE ACETONIDE | 0.05% | OINTMENT;TOPICAL | TRIAMCINOLONE ACETONIDE IN ABSORBASE | CMP PHARMA INC | ANDA | 23-Mar-95 | RX |
MEBENDAZOLE | 100MG | TABLET, CHEWABLE;ORAL | EMVERM | AMEDRA PHARMACEUTICALS LLC | ANDA | 04-Jan-95 | RX |
DALTEPARIN SODIUM | 2,500IU/0.2ML (12,500IU/ML) | INJECTABLE;SUBCUTANEOUS | FRAGMIN | PFIZER INC | NDA | 22-Dec-94 | RX |
TECHNETIUM TC-99M BICISATE KIT | N/A | INJECTABLE;INJECTION | NEUROLITE | LANTHEUS MEDICAL IMAGING INC | NDA | 23-Nov-94 | RX |
INDIUM IN-111 CHLORIDE | 5mCi/0.5ML | INJECTABLE;INJECTION | INDIUM IN 111 CHLORIDE | MALLINCKRODT NUCLEAR MEDICINE LLC | NDA | 27-Sep-94 | RX |
CYSTEAMINE BITARTRATE | EQ 50MG BASE | CAPSULE;ORAL | CYSTAGON | MYLAN PHARMACEUTICALS INC | NDA | 15-Aug-94 | RX |
AMINOSALICYLIC ACID | 4GM/PACKET | GRANULE, DELAYED RELEASE;ORAL | PASER | JACOBUS PHARMACEUTICAL CO | ANDA | 30-Jun-94 | RX |
ISONIAZID; PYRAZINAMIDE; RIFAMPIN | 50MG;300MG;120MG | TABLET;ORAL | RIFATER | SANOFI AVENTIS US LLC | NDA | 31-May-94 | RX |
IMIGLUCERASE | 200 UNITS/VIAL | INJECTABLE;INJECTION | CEREZYME | GENZYME CORP | NDA | 23-May-94 | RX |
TACROLIMUS | EQ 5MG BASE/ML | INJECTABLE;INJECTION | PROGRAF | ASTELLAS PHARMA US INC | NDA | 08-Apr-94 | RX |
DOXEPIN HYDROCHLORIDE | 5% | CREAM;TOPICAL | ZONALON | MYLAN PHARMACEUTICALS INC | NDA | 01-Apr-94 | RX |
ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE | 8MG;60MG | CAPSULE;ORAL | SEMPREX-D | AUXILIUM PHARMACEUTICALS INC | NDA | 25-Mar-94 | RX |
SUCRALFATE | 1GM/10ML | SUSPENSION;ORAL | CARAFATE | FOREST LABORATORIES INC | NDA | 16-Dec-93 | RX |
ALPRAZOLAM | 1MG/ML | CONCENTRATE;ORAL | ALPRAZOLAM | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | ANDA | 31-Oct-93 | RX |
LODOXAMIDE TROMETHAMINE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | ALOMIDE | NOVARTIS PHARMACEUTICALS CORP | NDA | 23-Sep-93 | RX |
MESALAMINE | 250MG | CAPSULE, EXTENDED RELEASE;ORAL | PENTASA | SHIRE DEVELOPMENT INC | NDA | 10-May-93 | RX |
VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/100ML | INJECTABLE;INJECTION | VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | 29-Apr-93 | RX |
GADODIAMIDE | 287MG/ML | INJECTABLE;INJECTION | OMNISCAN | GE HEALTHCARE | NDA | 08-Jan-93 | RX |
INDIUM IN-111 CHLORIDE | 2mCi/0.2ML | INJECTABLE;INJECTION | INDICLOR | GE HEALTHCARE | NDA | 29-Dec-92 | RX |
DINOPROSTONE | 0.5MG/3GM | GEL;ENDOCERVICAL | PREPIDIL | PHARMACIA AND UPJOHN CO | NDA | 09-Dec-92 | RX |
AVOBENZONE; OCTINOXATE; OXYBENZONE | 3%;7.5%;3% | LOTION;TOPICAL | SHADE UVAGUARD | BAYER HEALTHCARE LLC | NDA | 07-Dec-92 | OTC |
POTASSIUM CHLORIDE | 745MG/100ML | INJECTABLE;INJECTION | POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | ICU MEDICAL INC | NDA | 30-Nov-92 | RX |
OXICONAZOLE NITRATE | EQ 1% BASE | LOTION;TOPICAL | OXISTAT | FOUGERA PHARMACEUTICALS INC | NDA | 30-Sep-92 | RX |
DESFLURANE | 99.90% | LIQUID;INHALATION | SUPRANE | BAXTER HEALTHCARE CORP | NDA | 18-Sep-92 | RX |
SODIUM CHLORIDE | 0.90% | AEROSOL, METERED;INHALATION | BRONCHO SALINE | BLAIREX LABORATORIES INC | NDA | 03-Sep-92 | OTC |
INDOMETHACIN | 50MG | SUPPOSITORY;RECTAL | INDOMETHACIN | G AND W LABORATORIES INC | ANDA | 31-Aug-92 | RX |
TENIPOSIDE | 10MG/ML | INJECTABLE;INJECTION | VUMON | HQ SPECIALTY PHARMA | NDA | 14-Jul-92 | RX |
HYDROCORTISONE | 2.50% | SOLUTION;TOPICAL | TEXACORT | MISSION PHARMACAL CO | ANDA | 17-Apr-92 | RX |
THEOPHYLLINE | 400MG | CAPSULE, EXTENDED RELEASE;ORAL | THEO-24 | AUXILIUM PHARMACEUTICALS INC | ANDA | 28-Feb-92 | RX |
HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE | 1%;0.25% | SOLUTION/DROPS;OPHTHALMIC | PAREMYD | AKORN INC | NDA | 30-Jan-92 | RX |
BERACTANT | 25MG/ML | SUSPENSION;INTRATRACHEAL | SURVANTA | ABBVIE INC | NDA | 01-Jul-91 | RX |
ALTRETAMINE | 50MG | CAPSULE;ORAL | HEXALEN | EISAI INC | NDA | 26-Dec-90 | RX |
CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE | 6.602GM/100ML;198MG/100ML;3.177GM/100ML | SOLUTION;IRRIGATION | RENACIDIN | UNITED GUARDIAN INC | NDA | 02-Oct-90 | RX |
FLUOCINOLONE ACETONIDE | 0.01% | SHAMPOO;TOPICAL | CAPEX | GALDERMA LABORATORIES LP | NDA | 27-Aug-90 | RX |
OLSALAZINE SODIUM | 250MG | CAPSULE;ORAL | DIPENTUM | MYLAN SPECIALTY LP | NDA | 31-Jul-90 | RX |
TOBRAMYCIN SULFATE | EQ 80MG BASE/100ML | INJECTABLE;INJECTION | TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HOSPIRA INC | ANDA | 31-Jul-90 | RX |
PENICILLIN G POTASSIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | 25-Jun-90 | RX |
NAFTIFINE HYDROCHLORIDE | 1% | GEL;TOPICAL | NAFTIN | SEBELA IRELAND LTD | NDA | 18-Jun-90 | RX |
TECHNETIUM TC-99M MERTIATIDE KIT | N/A | INJECTABLE;INJECTION | TECHNESCAN MAG3 | MALLINCKRODT NUCLEAR MEDICINE LLC | NDA | 15-Jun-90 | RX |
PEGADEMASE BOVINE | 250 UNITS/ML | INJECTABLE;INJECTION | ADAGEN | SIGMA TAU PHARMACEUTICALS INC | NDA | 21-Mar-90 | RX |
NAFARELIN ACETATE | EQ 0.2MG BASE/SPRAY | SPRAY, METERED;NASAL | SYNAREL | GD SEARLE LLC | NDA | 13-Feb-90 | RX |
BETAXOLOL HYDROCHLORIDE | EQ 0.25% BASE | SUSPENSION/DROPS;OPHTHALMIC | BETOPTIC S | NOVARTIS PHARMACEUTICALS CORP | NDA | 29-Dec-89 | RX |
RUBIDIUM CHLORIDE RB-82 | N/A | INJECTABLE;INJECTION | CARDIOGEN-82 | BRACCO DIAGNOSTICS INC | NDA | 29-Dec-89 | RX |
GENTAMICIN SULFATE; PREDNISOLONE ACETATE | EQ 0.3% BASE;0.6% | OINTMENT;OPHTHALMIC | PRED-G | ALLERGAN PHARMACEUTICAL | NDA | 01-Dec-89 | RX |
NAFCILLIN SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | NALLPEN IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | 31-Oct-89 | RX |
OXACILLIN SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | BACTOCILL IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA | 26-Oct-89 | RX |
PENTAMIDINE ISETHIONATE | 300MG/VIAL | FOR SOLUTION;INHALATION | NEBUPENT | FRESENIUS KABI USA LLC | NDA | 15-Jun-89 | RX |
AZTREONAM | 40MG/ML | INJECTABLE;INJECTION | AZACTAM IN PLASTIC CONTAINER | BRISTOL MYERS SQUIBB CO | NDA | 24-May-89 | RX |
POVIDONE-IODINE | 1% | SOLUTION;TOPICAL | POVIDONE IODINE | ALLEGIANCE HEALTHCARE CORP | NDA | 31-Mar-89 | OTC |
SULCONAZOLE NITRATE | 1% | CREAM;TOPICAL | EXELDERM | RANBAXY LABORATORIES INC | NDA | 28-Feb-89 | RX |
TECHNETIUM TC-99M EXAMETAZIME KIT | N/A | INJECTABLE;INJECTION | CERETEC | GE HEALTHCARE | NDA | 30-Dec-88 | RX |
ETHANOLAMINE OLEATE | 50MG/ML | INJECTABLE;INJECTION | ETHAMOLIN | QOL MEDICAL LLC | NDA | 22-Dec-88 | RX |
DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | DIAZEPAM | HOSPIRA INC | ANDA | 20-Dec-88 | RX |
POTASSIUM CHLORIDE; SODIUM CHLORIDE | 149MG/100ML;900MG/100ML | INJECTABLE;INJECTION | POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | ICU MEDICAL INC | NDA | 17-Oct-88 | RX |
DEXAMETHASONE; TOBRAMYCIN | 0.1%;0.3% | OINTMENT;OPHTHALMIC | TOBRADEX | NOVARTIS PHARMACEUTICALS CORP | NDA | 28-Sep-88 | RX |
TIOPRONIN | 100MG | TABLET;ORAL | THIOLA | MISSION PHARMACAL CO | NDA | 11-Aug-88 | RX |
NITROGLYCERIN | 2% | OINTMENT;TRANSDERMAL | NITROGLYCERIN | FOUGERA PHARMACEUTICALS INC | ANDA | 08-Jul-88 | RX |
GENTAMICIN SULFATE; PREDNISOLONE ACETATE | EQ 0.3% BASE;1% | SUSPENSION/DROPS;OPHTHALMIC | PRED-G | ALLERGAN PHARMACEUTICAL | NDA | 10-Jun-88 | RX |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 10MG/100ML;2.5GM/100ML; 15MG/100ML; 300MG/100ML;160MG/100ML | INJECTABLE;INJECTION | DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER\'S IN PLASTIC CONTAINER | B BRAUN MEDICAL INC | NDA | 24-Feb-88 | RX |
DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;110MG/100ML | INJECTABLE;INJECTION | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | B BRAUN MEDICAL INC | NDA | 24-Feb-88 | RX |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;37MG/100ML;110MG/100ML | INJECTABLE;INJECTION | POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | B BRAUN MEDICAL INC | NDA | 17-Feb-88 | RX |
APRACLONIDINE HYDROCHLORIDE | EQ 1% BASE | SOLUTION/DROPS;OPHTHALMIC | IOPIDINE | NOVARTIS PHARMACEUTICALS CORP | NDA | 31-Dec-87 | RX |
DIAZEPAM | 50MG/10ML (5MG/ML) | INJECTABLE;INJECTION | DIAZEPAM | HOSPIRA INC | ANDA | 13-Oct-87 | RX |
VINBLASTINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | VINBLASTINE SULFATE | FRESENIUS KABI USA LLC | ANDA | 29-Apr-87 | RX |
FUROSEMIDE | 40MG/5ML | SOLUTION;ORAL | FUROSEMIDE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | ANDA | 22-Apr-87 | RX |
AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | POWDER;INTRAVENOUS | AMPICILLIN SODIUM | SANDOZ INC | ANDA | 19-Feb-87 | RX |
POVIDONE-IODINE | 10% | SPONGE;TOPICAL | E-Z SCRUB 241 | BECTON DICKINSON AND CO | NDA | 07-Jan-87 | OTC |
OXACILLIN SODIUM | EQ 1GM BASE/VIAL | POWDER;INTRAVENOUS | OXACILLIN SODIUM | SANDOZ INC | ANDA | 23-Dec-86 | RX |
POVIDONE-IODINE | 5% | SOLUTION/DROPS;OPHTHALMIC | BETADINE | ALCON PHARMACEUTICALS LTD | NDA | 17-Dec-86 | RX |
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | 0.2%;10% | OINTMENT;OPHTHALMIC | BLEPHAMIDE S.O.P. | ALLERGAN PHARMACEUTICAL | ANDA | 03-Dec-86 | RX |
METHACHOLINE CHLORIDE | 100MG/VIAL | FOR SOLUTION;INHALATION | PROVOCHOLINE | METHAPHARM INC | NDA | 31-Oct-86 | RX |
DOPAMINE HYDROCHLORIDE | 40MG/100ML | INJECTABLE;INJECTION | DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER | B BRAUN MEDICAL INC | NDA | 15-Oct-86 | RX |
ERYTHROMYCIN | 333MG | TABLET, COATED PARTICLES;ORAL | PCE | ARBOR PHARMACEUTICALS LLC | NDA | 09-Sep-86 | RX |
CUPRIC CHLORIDE | EQ 0.4MG COPPER/ML | INJECTABLE;INJECTION | CUPRIC CHLORIDE IN PLASTIC CONTAINER | HOSPIRA INC | NDA | 26-Jun-86 | RX |
MANGANESE CHLORIDE | EQ 0.1MG MANGANESE/ML | INJECTABLE;INJECTION | MANGANESE CHLORIDE IN PLASTIC CONTAINER | HOSPIRA INC | NDA | 26-Jun-86 | RX |
ZINC CHLORIDE | EQ 1MG ZINC/ML | INJECTABLE;INJECTION | ZINC CHLORIDE IN PLASTIC CONTAINER | HOSPIRA INC | NDA | 26-Jun-86 | RX |
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS | 5GM/100ML; 30MG/100ML; 141MG/100ML; 15MG/100ML; 260MG/100ML; 25MG/100ML | INJECTABLE;INJECTION | IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER | ICU MEDICAL INC | NDA | 08-May-86 | RX |
FLUOROMETHOLONE | 0.25% | SUSPENSION/DROPS;OPHTHALMIC | FML FORTE | ALLERGAN PHARMACEUTICAL | NDA | 23-Apr-86 | RX |
FLUOROMETHOLONE ACETATE | 0.10% | SUSPENSION/DROPS;OPHTHALMIC | FLAREX | NOVARTIS PHARMACEUTICALS CORP | NDA | 11-Feb-86 | RX |
IOHEXOL | 38.80% | SOLUTION;INJECTION, ORAL, RECTAL | OMNIPAQUE 180 | GE HEALTHCARE | NDA | 26-Dec-85 | RX |
NABILONE | 1MG | CAPSULE;ORAL | CESAMET | MYLAN SPECIALTY LP | NDA | 26-Dec-85 | RX |
INDIUM IN-111 OXYQUINOLINE | 1mCi/ML | INJECTABLE;INJECTION | INDIUM IN 111 OXYQUINOLINE | GE HEALTHCARE | NDA | 24-Dec-85 | RX |
POVIDONE-IODINE | 20% | SPONGE;TOPICAL | E-Z SCRUB 201 | BECTON DICKINSON AND CO | NDA | 29-Nov-85 | OTC |
TRIENTINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | SYPRINE | ATON PHARMA INC | NDA | 08-Nov-85 | RX |
FLUOROMETHOLONE | 0.10% | OINTMENT;OPHTHALMIC | FML | ALLERGAN PHARMACEUTICAL | NDA | 04-Sep-85 | RX |
SULCONAZOLE NITRATE | 1% | SOLUTION;TOPICAL | EXELDERM | SUN PHARMACEUTICAL INDUSTRIES LTD | NDA | 30-Aug-85 | RX |
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | CREAM;TOPICAL | CORTISPORIN | MONARCH PHARMACEUTICALS LLC | NDA | 09-Aug-85 | RX |
AURANOFIN | 3MG | CAPSULE;ORAL | RIDAURA | SEBELA IRELAND LTD | NDA | 24-May-85 | RX |
PREDNISONE | 5MG/ML | SOLUTION;ORAL | PREDNISONE INTENSOL | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | ANDA | 20-Feb-85 | RX |
MEPERIDINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | MEPERIDINE HYDROCHLORIDE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | ANDA | 30-Jan-85 | RX |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE | EQ 0.01MG BASE/ML;2% | INJECTABLE;INJECTION | LIGNOSPAN STANDARD | DEPROCO INC | ANDA | 22-Jan-85 | RX |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE | EQ 0.02MG BASE/ML;2% | INJECTABLE;INJECTION | LIGNOSPAN FORTE | DEPROCO INC | ANDA | 22-Jan-85 | RX |
ERYTHROMYCIN | 2% | OINTMENT;TOPICAL | AKNE-MYCIN | DOW PHARMACEUTICAL SCIENCES | NDA | 10-Jan-85 | RX |
CHLORHEXIDINE GLUCONATE | 4% | AEROSOL, METERED;TOPICAL | EXIDINE | XTTRIUM LABORATORIES INC | NDA | 24-Dec-84 | OTC |
COPPER | 309MG/COPPER | INTRAUTERINE DEVICE;INTRAUTERINE | PARAGARD T 380A | TEVA WOMENS HEALTH INC | NDA | 15-Nov-84 | RX |
SODIUM LACTATE | 5MEQ/ML | INJECTABLE;INJECTION | SODIUM LACTATE IN PLASTIC CONTAINER | HOSPIRA INC | NDA | 05-Sep-84 | RX |
AMOXICILLIN; CLAVULANATE POTASSIUM | 125MG/5ML;EQ 31.25MG BASE/5ML | FOR SUSPENSION;ORAL | AUGMENTIN \'125\' | DR REDDYS LABORATORIES INC | NDA | 06-Aug-84 | RX |
SODIUM CHLORIDE | 2.5MEQ/ML | INJECTABLE;INJECTION | SODIUM CHLORIDE IN PLASTIC CONTAINER | HOSPIRA INC | NDA | 20-Jul-84 | RX |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML; 37MG/100ML; 370MG/100ML; 530MG/100ML; 500MG/100ML | SOLUTION;IRRIGATION | PHYSIOLYTE IN PLASTIC CONTAINER | B BRAUN MEDICAL INC | NDA | 08-Jun-84 | RX |
ESTRADIOL | 0.01% | CREAM;VAGINAL | ESTRACE | ALLERGAN SALES LLC | ANDA | 31-Jan-84 | RX |
CAFFEINE; ERGOTAMINE TARTRATE | 100MG;2MG | SUPPOSITORY;RECTAL | MIGERGOT | HORIZON PHARMA RHEUMATOLOGY LLC | ANDA | 04-Oct-83 | RX |
DEXAMETHASONE | 1MG | TABLET;ORAL | DEXAMETHASONE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | ANDA | 15-Sep-83 | RX |
DEXAMETHASONE | 1MG/ML | CONCENTRATE;ORAL | DEXAMETHASONE INTENSOL | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | ANDA | 01-Sep-83 | RX |
DEXAMETHASONE | 0.5MG/5ML | SOLUTION;ORAL | DEXAMETHASONE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | ANDA | 01-Sep-83 | RX |
ACETOHYDROXAMIC ACID | 250MG | TABLET;ORAL | LITHOSTAT | MISSION PHARMACAL CO | NDA | 31-May-83 | RX |
OXTRIPHYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | CHOLEDYL SA | WARNER CHILCOTT CO LLC | ANDA | 24-May-83 | RX |
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | 142MG/ML;276MG/ML | INJECTABLE;INJECTION | SODIUM PHOSPHATES IN PLASTIC CONTAINER | HOSPIRA INC | NDA | 10-May-83 | RX |
SODIUM ACETATE ANHYDROUS | 2MEQ/ML | INJECTABLE;INJECTION | SODIUM ACETATE IN PLASTIC CONTAINER | HOSPIRA INC | NDA | 04-May-83 | RX |
NONOXYNOL-9 | 1GM | SPONGE;VAGINAL | TODAY | MAYER LABORATORIES INC | NDA | 01-Apr-83 | OTC |
PRAZIQUANTEL | 600MG | TABLET;ORAL | BILTRICIDE | BAYER HEALTHCARE PHARMACEUTICALS INC | NDA | 29-Dec-82 | RX |
DEXAMETHASONE | 2MG | TABLET;ORAL | DEXAMETHASONE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | ANDA | 26-Aug-82 | RX |
DISOPYRAMIDE PHOSPHATE | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | NORPACE CR | GD SEARLE LLC | NDA | 20-Jul-82 | RX |
AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 3%; 26MG/100ML; 3GM/100ML; 54MG/100ML; 41MG/100ML;150MG/100ML; 200MG/100ML; 120MG/100ML | INJECTABLE;INJECTION | PROCALAMINE | B BRAUN MEDICAL INC | NDA | 08-May-82 | RX |
STREPTOZOCIN | 1GM/VIAL | INJECTABLE;INJECTION | ZANOSAR | TEVA PHARMACEUTICALS USA | NDA | 07-May-82 | RX |
TECHNETIUM TC-99M DISOFENIN KIT | N/A | INJECTABLE;INJECTION | HEPATOLITE | PHARMALUCENCE INC | NDA | 16-Mar-82 | RX |
INDIUM IN-111 PENTETATE DISODIUM | 1mCi/ML | INJECTABLE;INTRATHECAL | MPI INDIUM DTPA IN 111 | GE HEALTHCARE | NDA | 18-Feb-82 | RX |
HYDROCORTISONE ACETATE | 10% | AEROSOL, METERED;RECTAL | CORTIFOAM | MYLAN SPECIALTY LP | NDA | 10-Feb-82 | RX |
ETHINYL ESTRADIOL; NORELGESTROMIN | 0.035MG/24HR;0.15MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | XULANE | MYLAN TECHNOLOGIES INC | ANDA | 16-Apr-14 | RX |