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 1RPR106721 - POMA (INTERMEDIATE)
143 1SALICYLIC ACID
144 1SAR441236
145 1SAREDUTANT SUCCINATE DRUG SUBSTANCE
146 1SATAVAPTAN PHOSPHATE MONOHYDRATE DRUG SUBSTANCE
147 1SEMULOPARIN SODIUM
148 1SN-1, 2-DIPALMITOY1-3-PHOSPHATIDYLCHOLINE (DPPC)
149 1SN-1-PALMITOYL-2-OLEOYLPHOSPHATIDYLGLYCEROL SODIUM SALT (POPG.NA)
150 1SODIUM CHOLESTERYL SULPHATE
151 1SPIRAMYCIN BASE
152 1SPIRAMYCIN SYRUP
153 1SPIROMETHYL-BIPHENYL-NITRILE (SR47563)
154 1SR 27417A
155 1STREPTOMYCIN SULFATE
156 1SUCCIMER (MESO-2,3-DIMERCAPTOSUCCINIC ACID)
157 1SUPROCLONE (37,162 RP)
158 1SUPROCLONE CAPSULES (37, 162 RP)
159 1SURICLONE (31, 264 R.P.)
160 1TESTOSTERONE (DIOSYNTH BV)
161 1TESTOSTERONE CYPIONATE
162 1TESTOSTERONE ENANTHATE
163 1TESTOSTERONE PROPIONATE
164 1TILUDRONATE DISODIUM DRUG SUBSTANCE
165 1TRIAMCINOLONE
166 1TRIAMCINOLONE 21-ACETATE
167 1TRIAMCINOLONE ACETATE AND TRIAMCINOLONE (ALCOHOL)
168 1TRIAMCINOLONE ACETONIDE
169 1TRIAMCINOLONE HEXACETONIDE
170 1TRIAMCINOLONE USP
171 2TRIAMTERENE
172 1TRIFLUOPERAZINE CHLORHYDRATE
173 1TRIMEGESTONE
174 1TRIMEPRAZINE TARTRATE
175 1TRIMIPRAMINE MALEATE
176 1TRIPROLIDINE HCL.
177 1TYROPANOATE SODIUM
178 1VERAPAMIL HYDROCHLORIDE
179 1ZOLPIDEM TARTRATE
180 1ZOPICLONE (26,267 R.P.)
GDUFA
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Rev. Date :
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Submission : 2004-01-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2399
Submission : 1975-02-11
Status : Inactive
Type : II
GDUFA
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Pay. Date :
DMF Number : 11994
Submission : 1996-06-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10996
Submission : 1994-07-21
Status : Inactive
Type : II
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 9957
Submission : 1992-11-10
Status : Inactive
Type : II
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 9382
Submission : 1991-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3593
Submission : 1979-06-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5148
Submission : 1983-11-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5048
Submission : 1983-07-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3142
Submission : 1978-02-01
Status : Inactive
Type : II
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