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    01 11-(A-HYDROXYETHYL)-2-METHYL-5-NITRO-IMIDAZOLE,A NEW TRICHOMONOCIDE

    02 11-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL, AMMONIUM SALT (POPG, NH4)

    03 117-DEACETYLNORGESTIMATE (NORELGESTROMIN)

    04 119-NOR-ANDROSTENEDIONE (NANDROLONE)

    05 15,6-DIMETHOXY-1-INDANONE

    06 15-METHYLSULFONAMIDOINDOLE-2-CARBOXYLIC ACID

    07 2ACEBUTOLOL HYDROCHLORIDE

    08 1ACESULFAME K (ACETOSULFAM-KGERMAN)

    09 1ACETAMINOFEN

    10 1ACETAMINOPHEN

    11 1ACETAMINOPHEN (BULK)

    12 1ADENO-ASSOCIATED VIRUS (AAV) VECTOR CONTAINING THE GENE FOR HUMAN BLOOD COAGULATION FACTOR IX (COAGULIN-B)

    13 1ALFUZOSIN HYDROCHLORIDE

    14 1ALFUZOSIN HYDROCHLORIDE DRUG SUBSTANCE

    15 1ARTESUNATE

    16 1AVANAFIL

    17 1BECLOMETHASONE DIPROPIONATE USP

    18 1BEFLOXATONE

    19 1BETAMETHASONE ACETATE

    20 1BIOPAL VRO-20

    21 1BULK PROTIRELIN (THYROID RELEASING HORMONE; TRH) DRUG SUBSTANCE

    22 1CABAZITAXEL ACETONE SOLVATE

    23 1CERAMIDETRIHEXOSIDASE

    24 1CHENODEOXYCHOLIC ACID

    25 1CHLORAZEPATE MONOPOTASSIUM

    26 1CHLORMEZANONE

    27 1CHLOROQUINE BASE AND PHOSPHATE

    28 1CHLORPROMAZINE HYDROCHLORIDE

    29 1CIRAMADOL HYDROCHLORIDE

    30 2CLINDAMYCIN PHOSPHATE

    31 2CLOPIDOGREL BISULFATE

    32 1CLOPIDOGREL BISULFATE FORM I

    33 1CLOPIDOGREL BISULFATE FORM II

    34 1CLOROQUINE PHOSPHATE

    35 1CLOTRIMAZOLE

    36 1COLCHICINE

    37 1CONTRACT PACKAGING OPERATIONS ONLY, LOCATED IN FENTON, MO

    38 1CORTISONE ACETATE

    39 1D-PROPOXYPHENE HYDROCHLORIDE BULK

    40 1DAUNORUBICIN HYDROCHLORIDE

    41 1DELTA-5 (10)-NORANDROSTENEDIONE

    42 1DESERPIDINE

    43 1DIATRIZOATE SODIUM USP

    44 1DIHYDROERGOTOXIN MESYLATE

    45 1DIHYDROSTREPTOMYCIN SULFATE

    46 1DIHYDROTACHYSTEROL

    47 1DISOPYRAMIDE PHOSPHATE

    48 1DOBUTAMINE ISONICOTINATE/ OFF-0358-A-01-1

    49 1DRONEDARONE HYDROCHLORIDE

    50 1ELS(ELASTASE)

    51 1EPLIVANSERIN HEMIFUMARATE

    52 1ESBIOL

    53 1ESTRADIOL

    54 1ESTRADIOL USP

    55 1ESTRADIOL VALERATE

    56 1ESTRONE

    57 1ETHAMBUTOL HYDROCHLORIDE

    58 1ETHINYL ESTRADIOL

    59 1ETHIONAMIDE SUPPOSITORIES, 500 MG, THERAPLIX SA, PARIS, FR

    60 1FACILITIES LOCATED IN SISTERON, FRNACE

    61 1FACILITIES UTILIZED IN MONTPELLIER, FRANCE

    62 1FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT BUDAPEST, HUNGARY

    63 1FACILITY LOCATED IN SISTERON, FRANCE

    64 1FLUPREDNYLIDENE-21-ACETATE

    65 1FLURAZEPAM HYDROCHLORIDE

    66 1FONDAPARINUX SODIUM

    67 1FOR STERLING-WINTHROP RESEARCH CENTRE IN ALNWICK

    68 1FUMARATE (30,356 R.P.)

    69 1GUAIFENESIN (GLYCEROL GUAIACOLATE)

    70 1HEMATOPORPHYRIN BASE

    71 1HEMATOPORPHYRIN HCL

    72 1HEMATOROPHYRINE DIHYDROCHLORIDE,PACKAGED AND TESTED IN VERTOLAYE,FRANCE

    73 1HEPARIN SODIUM

    74 1HMMP

    75 1HMMP [2-HYDROXYMETHYL-4-(3-METHOXYPROPOXY)-3-METHYLPYRIDINE]

    76 1HMR 1275

    77 1HPLC PURIFIED CALCITONIN-SALMON DRUG SUBSTANCE

    78 1HUMAN INSULIN-SEMISYNTHETIC, BULK MATRLS & FINISHED DOS. FORM

    79 1HYDROCHLOROTHIAZIDE

    80 1HYDROCORTISONE SODIUM PHOSPHATE

    81 2HYDROXY ACID

    82 1IGEPAL CA 630 SPECIAL (OCTOXYNOL-9)

    83 1IGEPAL CA-630G (OCTOXYNOL 9)

    84 1IGEPAL CO 887 (SAME AS IGEPAL 880) CONTRLS & TOXICITY

    85 1IRBESARTAN DRUG SUBSTANCE

    86 1ISOETHARINE MESYLATE AND ISOETHARINE HYDROCHLORIDE

    87 1L-5-HYDROXYTRYPTOPHAN

    88 1LEUPROLIDE ACETATE

    89 1LEVONORDEFRIN MNFG AT RENSSELAER, NY FACILITIES

    90 1LIDOCAINE HCL

    91 1LINDANE

    92 1MANUF RESCH AND PERSONNEL FILE RSCH FACILS, EQUIPMENT & CONTROLS 11-16

    93 1MANUFACTURING FACILITIES AND CONTROLS

    94 1MANUFACTURING FACILITIES AT NOTRE DAME DE BONDEVILLE, FRANCE

    95 1MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT COLLEGEVIEW, PA

    96 1MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN AMBARES, FRANCE.

    97 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ARAMON.

    98 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FAWDON, NEWCASTLE TYNE NE3 3TT, ENGLAND.

    99 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LABEGE CEDEX, FRANCE

    100 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LIESTAL, SWITZERLAND.

    101 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOULOUSE, FRANCE.

    102 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF 5,6-DIMETHOXY-1-INDANONE

    103 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

    104 1MDL 101,731

    105 1MDL 104036

    106 1MDL 105074

    107 1MEGLUMINE ANTIMONIATE (GLUCANTIME)

    108 1MEPHENTERMINE (BASE & SULFATE)

    109 1MESTRANOL

    110 1METHYLOXINE BROMOMETHYLOXINE METHYLOXINE N-DODECYLSULFATE

    111 1METHYLPREDNISOLONE ACETATE

    112 1METHYLPREDNISOLONE HEMISUCCINATE

    113 1METHYLTESTOSTERONE USP

    114 1METRONIDAZOLE

    115 1MINAPRINE

    116 1N-[2-(5-METHOXYINDOL-3-YL)ETHYL] ACETAMIDE (MELATONIN)

    117 1NADROPARIN CALCIUM

    118 1NALMEFENE HYDROCHLORIDE

    119 1NEDOCROMIL SODIUM

    120 1NEOMYCIN SULFATE

    121 2NORETHINDRONE

    122 1NORETHINDRONE ACETATE

    123 1NORGESTERAL ACETATE OXIME

    124 1NORTON PLASTIC S-500-304

    125 1OMEPRAZOLE

    126 1ORUVAIL 200 MG. CAPSULES

    127 1OXYBUTYNIN CHLORIDE

    128 1PEGYLATED RECOMBINANT ANIT-PSEUDOMONAS AERUGINOSA PCRV FAB' ANTIBODY (KB001-A) DRUG PRODUCT

    129 1PEGYLATED RECOMBINANT ANTI-PSEUDOMONAS AERUGINOSA PCRV FAB' ANTIBODY (KB001-A) DRUG SUBSTANCE

    130 1PENTAMIDINE ISETHIONATE

    131 1PHOSPHOLIPON 80

    132 1PHOSPHOLIPON 90

    133 1PHOSPHOLIPON MC (DMPC)

    134 1PHOSPHOLIPON MG-NH4

    135 1PROCHLORPERAZINE EDISYLATE

    136 1PROMAZINE HYDROCHLORIDE

    137 1PROMETHAZINE HCL

    138 1PROPIONYL PROMAZINE (PROPIOPROMAZINE)

    139 1PYRAZINAMIDE

    140 1R-ZACOPRIDE

    141 1RIMONABANT

    142 1SALICYLIC ACID

    143 1SAR441236

    144 1SAREDUTANT SUCCINATE DRUG SUBSTANCE

    145 1SATAVAPTAN PHOSPHATE MONOHYDRATE DRUG SUBSTANCE

    146 1SEMULOPARIN SODIUM

    147 1SN-1, 2-DIPALMITOY1-3-PHOSPHATIDYLCHOLINE (DPPC)

    148 1SN-1-PALMITOYL-2-OLEOYLPHOSPHATIDYLGLYCEROL SODIUM SALT (POPG.NA)

    149 1SODIUM CHOLESTERYL SULPHATE

    150 1SPIRAMYCIN BASE

    151 1SPIRAMYCIN SYRUP

    152 1SPIROMETHYL-BIPHENYL-NITRILE (SR47563)

    153 1SR 27417A

    154 1STREPTOMYCIN SULFATE

    155 1SUCCIMER (MESO-2,3-DIMERCAPTOSUCCINIC ACID)

    156 1SUPROCLONE (37,162 RP)

    157 1SUPROCLONE CAPSULES (37, 162 RP)

    158 1SURICLONE (31, 264 R.P.)

    159 1TESTOSTERONE (DIOSYNTH BV)

    160 1TESTOSTERONE CYPIONATE

    161 1TESTOSTERONE ENANTHATE

    162 1TESTOSTERONE PROPIONATE

    163 1TILUDRONATE DISODIUM DRUG SUBSTANCE

    164 1TRIAMCINOLONE

    165 1TRIAMCINOLONE 21-ACETATE

    166 1TRIAMCINOLONE ACETATE AND TRIAMCINOLONE (ALCOHOL)

    167 1TRIAMCINOLONE ACETONIDE

    168 1TRIAMCINOLONE HEXACETONIDE

    169 1TRIAMCINOLONE USP

    170 2TRIAMTERENE

    171 1TRIFLUOPERAZINE CHLORHYDRATE

    172 1TRIMEGESTONE

    173 1TRIMEPRAZINE TARTRATE

    174 1TRIMIPRAMINE MALEATE

    175 1TRIPROLIDINE HCL.

    176 1TYROPANOATE SODIUM

    177 1VERAPAMIL HYDROCHLORIDE

    178 1ZOLPIDEM TARTRATE

    179 1ZOPICLONE (26,267 R.P.)

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    01

    17-deacetylnorgestimate (norelgestro...

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    GDUFA

    DMF Review : N/A

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    DMF Number : 17115

    Submission : 2004-01-23

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    19-nor-androstenedione (nandrolone)

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    GDUFA

    DMF Review : N/A

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    DMF Number : 2399

    Submission : 1975-02-11

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    5,6-dimethoxy-1-indanone

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    GDUFA

    DMF Review : N/A

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    DMF Number : 11994

    Submission : 1996-06-04

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    5-methylsulfonamidoindole-2-carboxyl...

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    DMF Review : N/A

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    DMF Number : 10996

    Submission : 1994-07-21

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    Acebutolol Hydrochloride

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    DMF Review : N/A

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    DMF Number : 9382

    Submission : 1991-10-23

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    Acebutolol Hydrochloride

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    DMF Review : N/A

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    DMF Number : 9957

    Submission : 1992-11-10

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    07

    Acesulfame K (acetosulfam-kgerman)

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    DMF Review : N/A

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    DMF Number : 3593

    Submission : 1979-06-15

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    08

    Acetaminofen

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    DMF Review : N/A

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    DMF Number : 5148

    Submission : 1983-11-10

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    Acetaminophen

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    DMF Review : N/A

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    Submission : 1983-07-22

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    Acetaminophen (bulk)

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