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01 15-FLUOROURACIL
02 1ABIRATERONE ACETATE
03 1ACETAZOLAMIDE
04 1ACETYLSULFISOXAZOLE
05 1ACYCLOVIR
06 3ACYCLOVIR USP
07 1ADAPALENE USP
08 1AFATINIB DIMALEATE
09 1ALBUTEROL SULPHATE (SALBUTAMOL)
10 1ALCLOMETASONE DIPROPIONATE
11 1ALENDRONATE MONOSODIUM TRIHYDRATE
12 1ALLOPURINOL
13 1ALLOPURINOL USP
14 1ALPHA METHYLDOPA USP
15 2AMCINONIDE
16 1AMITRIPTYLINE HCL USP DRUG SUBSTANCE
17 1AMLODIPINE BESYLATE
18 1AMLODIPINE BESYLATE (PROCESS II)
19 1AMOXICILLIN SODIUM
20 1AMOXICILLIN TRIHYDRATE USP
21 1AMPICILLIN TRIHYDRATE
22 1ANASTROZOLE
23 1APIXABAN
24 1ARIPIPRAZOLE
25 1ARMODAFINIL
26 1ARMODAFINIL 7SM1029
27 1ATENOLOL
28 1ATOMOXETINE HYDROCHLORIDE
29 5ATORVASTATIN CALCIUM
30 1ATRACURIUM BESYLATE
31 1AZACITIDINE
32 1AZITHROMYCIN DIHYDRATE
33 2AZITHROMYCIN MONOHYDRATE
34 1AZITHROMYCIN N
35 1AZTREONAM
36 1AZTREONAM USP
37 1BECLOMETHASONE DIPROPIONATE
38 1BECLOMETHASONE DIPROPIONATE ANHYDROUS, BULK DRUG SUBSTANCE
39 1BECLOMETHASONE DIPROPIONATE MONOHYDRATE
40 1BETAMETHASONE ACETATE
41 1BETAMETHASONE DIPROPIONATE
42 1BETAMETHASONE VALERATE
43 1BICALUTAMIDE
44 1BIVALIRUDIN
45 1BLEOMYCIN SULFATE
46 1BORTEZOMIB
47 1BREXPIPRAZOLE
48 1BROMOCRIPTINE MESYLATE
49 2BUDESONIDE
50 1BUPRENORPHINE
51 1BUPRENORPHINE HYDROCHLORIDE
52 1BUTORPHANOL TARTRATE
53 1CABAZITAXEL
54 1CABERGOLINE
55 1CALCIPOTRIENE USP
56 1CALCITRIOL USP
57 1CANDESARTAN CILEXETIL
58 1CAPECITABINE
59 2CARBAMAZEPINE USP
60 1CARBIDOPA
61 1CARBIDOPA USP (DRUG SUBSTANCE)
62 1CARBOPLATIN
63 1CARFILZOMIB
64 1CARVEDILOL PHOSPHATE
65 1CARVEDILOL USP
66 1CASPOFUNGIN
67 1CASPOFUNGIN ACETATE
68 1CEFACLOR USP
69 1CEFADROXIL
70 1CEFAZOLIN SODIUM
71 1CEFDINIR HYDRATE
72 1CEFPROZIL
73 1CEPHALEXIN
74 1CEPHALOSPORIN G
75 1CEPHRADINE
76 1CHLORTHALIDONE
77 1CILOSTAZOL USP
78 1CINACALCET HYDROCHLORIDE
79 1CISATRACURIUM BESYLATE
80 1CLARITHROMYCIN USP
81 2CLOBETASOL PROPIONATE
82 1CLOMIPHENE CITRATE
83 1CLOPIDOGREL BISULFATE USP
84 1CLOXACILLIN SODIUM
85 1CO-POLYMER-1 (COP-1)
86 1CRISABOROLE
87 1CYCLACILLIN
88 2CYCLOSPORINE
89 1CYCLOSPORINE ID: 741310
90 1CYCLOSPORINE ID: 741710
91 1DABIGATRAN ETEXILATE MESYLATE
92 1DARIFENACIN HYDROBROMIDE
93 1DASATINIB ANHYDROUS
94 1DASATINIB MONOHYDRATE
95 1DAUNORUBICIN HYDROCHLORIDE
96 1DEFERASIROX
97 1DEFEROXAMINE MESYLATE
98 1DESFESOTERODINE SUCCINATE
99 1DESLORATADINE DRUG SUBSTANCE
100 1DESMOPRESSIN ACETATE USP
101 1DESONIDE
102 1DESVENLAFAXINE BASE
103 1DESVENLAFAXINE FUMARATE
104 1DESVENLAFAXINE SUCCINATE
105 1DESVENLAFAXINE SUCCINATE HPMC PRELIMINARY MIX
106 1DEXRAZOXANE (ICRF-187)
107 1DICLOXACILLIN SODIUM
108 1DIFLORASONE DIACETATE BULK DRUG
109 1DIFLUPREDNATE
110 1DIHYDRO DANE SALT
111 1DIHYDROERGOTAMINE MESYLATE
112 1DILTIAZEM HYDROCHLORIDE USP
113 2DIMETHYL FUMARATE
114 1DIROXIMEL FUMARATE
115 1DOCETAXEL
116 1DONEPEZIL HYDROCHLORIDE
117 1DORZOLAMIDE HCL
118 1DOXEPIN HCL USP
119 1DOXERCALCIFEROL
120 1DOXORUBICIN HYDROCHLORIDE
121 1DROSPIRENONE
122 1DULOXETINE HCL DRUG SUBSTANCE
123 1ELETRIPTAN HYDROBROMIDE
124 1EMPAGLIFLOZIN
125 1EPIRUBICIN HYDROCHLORIDE LYOPHILIZED
126 1EPIRUBICIN HYDROCHLORIDE PRECIPITATED
127 1EPTIFIBATIDE
128 1ERGOLOID MESYLATES
129 1ERGONOVINE MALEATE
130 1ERGOTAMINE TARTRATE
131 1ERLOTINIB HCL
132 1ESTROGENIC LIQUIDS
133 1ESTROGENIC POWDERS
134 1ESZOPICLONE ( PROCESS I )
135 1ESZOPICLONE (PROCESS II)
136 1ETODOLAC
137 1ETOPOSIDE
138 1EXENATIDE
139 1EZETIMIBE
140 1EZETIMIBE DRUG SUBSTANCE
141 1FAMCICLOVIR
142 1FEBUXOSTAT
143 1FENOFIBRATE CHOLINE
144 1FEXOFENADINE BASE
145 1FEXOFENADINE HYDROCHLORIDE
146 1FINGOLIMOD HYDROCHLORIDE
147 1FLUDARABINE PHOSPHATE
148 1FLUDROCORTISONE ACETATE
149 1FLUNISOLIDE ANHYDROUS
150 1FLUNISOLIDE ANHYDROUS (NEW PROCESS)
151 1FLUOCINOLONE ACETONIDE (PROCESS I)
152 1FLUOCINOLONE ACETONIDE - PROCESS II
153 1FLUOCINONIDE
154 1FLUOCINONIDE (NEW PROCESS)
155 1FLUOROMETHOLONE-17-ACETATE
156 1FLUOXETINE HCI
157 1FLUTICASONE PROPIONATE
158 1FLUVASTATIN SODIUM
159 1FLUVOXAMINE MALEATE
160 1FORMOTEROL FUMARATE DIHYDRATE
161 1FOSAMPRENAVIR CALCIUM
162 2FULVESTRANT
163 1FUROSEMIDE USP
164 1GABAPENTIN
165 1GABAPENTIN BUTANOL PROCESS
166 1GALANTHAMINE HYDROBROMIDE
167 1GATIFLOXACIN
168 1GEMCITABINE HYDROCHLORIDE
169 1GEMCITABINE HYDROCHLORIDE (A-MESYLRIBOSE PROCESS)
170 1GEMFIBROZIL USP
171 1HALOBETASOL PROPIONATE
172 1HALOPERIDOL
173 1HALOPERIDOL DECANOATE
174 2HYDROCHLOROTHIAZIDE
175 1HYDROCORTISONE BUTYRATE DRUG SUBSTANCE
176 1IBANDRONATE SODIUM
177 1IBRUTINIB
178 1ICATIBANT ACETATE
179 1IDARUBICIN HYDROCHLORIDE
180 1IMATINIB MESYLATE
181 1IMATINIB MESYLATE FORM ALPHA
182 1IMIPRAMINE HYDROCHLORIDE USP
183 1IMIQUIMOD
184 1IRBESARTAN
185 1IRBESARTAN USP
186 2LABETALOL HYDROCHLORIDE
187 1LACOSAMIDE
188 1LAMOTRIGINE
189 1LANSOPRAZOLE
190 1LATANOPROST
191 1LETROZOLE
192 1LEUPROLIDE ACETATE
193 1LEVALBUTEROL HYDROCHLORIDE
194 1LEVETIRACETAM
195 1LEVODOPA
196 1LEVOFLOXACIN
197 1LINACLOTIDE
198 1LINAGLIPTIN
199 1LINEZOLID
200 1LISINOPRIL DRUG SUBSTANCE
201 1LISURIDE
202 1LISURIDE HYDROGENMALEATE
203 1LOPERAMIDE HYDROCHLORIDE
204 1LORAZEPAM
205 2LOSARTAN POTASSIUM
206 1LOVASTATIN USP
207 1LR-103
208 1LUBIPROSTONE
209 1LURASIDONE HYDROCHLORIDE
210 1MACITENTAN
211 1MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN BEER SHEVA, ISREAL.
212 1MEDROXYPROGESTERONE ACETATE
213 1MEGESTROL ACETATE
214 1MEMANTINE HYDROCHLORIDE
215 1MESALAZINE N
216 1METFORMIN HYDROCHLORIDE DRUG SUBSTANCE
217 1METHYLDOPA
218 1METHYLERGONOVINE MALEATE USP
219 1METOPROLOL SUCCINATE
220 1METOPROLOL TARTRATE
221 1METOPROLOL TARTRATE USP
222 1MICAFUNGIN SODIUM
223 1MIRTAZAPINE
224 1MISOPROSTOL
225 1MISOPROSTOL HPMC DISPERSION 1:100
226 1MITOMYCIN
227 1MITOXANTRONE HYDROCHLORIDE USP
228 1MODAFINIL
229 1MOMETASONE FUROATE USP
230 2MONTELUKAST SODIUM
231 2MUPIROCIN
232 1MUPIROCIN CALCIUM
233 1MUPIROCIN CALCIUM DIHYDRATE
234 1MYCOPHENOLATE MOFETIL DRUG SUBSTANCE
235 1MYCOPHENOLATE SODIUM
236 1NAPROXEN
237 1NAPROXEN AND NAPROXEN SODIUM USP
238 1NAPROXEN SODIUM
239 1NATEGLINIDE
240 1NEFAZODONE HYDROCHLORIDE USP
241 1NIFEDIPINE
242 1NILOTINIB HYDROCHLORIDE
243 1NILOTINIB HYDROCHLORIDE FORM ALPHA
244 1NITISINONE
245 1NORGESTIMATE BULK DRUG SUBSTANCE
246 1OCTREOTIDE ACETATE
247 1OLANZAPINE USP
248 1OLMESARTAN MEDOXOMIL USP
249 1OMEPRAZOLE
250 1ONDANSETRON BASE
251 1ONDANSETRON HCL DIHYDRATE
252 1ONDANSETRON HYDROCHLORIDE DIHYDRATE
253 1OXACILLIN SODIUM
254 1OXALIPLATIN
255 1OXAZEPAM
256 1PACLITAXEL
257 1PACLITAXEL SEMISYNTHETIC
258 1PACLITAXEL SEMISYNTHETIC (9-DHB)
259 1PACLITAXEL SEMISYNTHETIC (FROM 10-DAB)
260 1PALBOCICLIB
261 1PALIPERIDONE
262 1PALONOSETRON HCL
263 1PALONOSETRON HYDROCHLORIDE
264 1PAMIDRONATE BULK CHEMICAL
265 1PANCURONIUM BROMIDE
266 2PANTOPRAZOLE SODIUM
267 1PARAHYDROXY DANE SALT
268 1PARICALCITOL USP
269 1PAROXETINE HYDROCHLORIDE HEMIHYDRATE
270 1PEMETREXED DIACID
271 1PENICILLIN G SULFOXIDE
272 1PENICILLIN V POTASSIUM
273 1PENTOXIFYLLINE USP
274 1PERAMPANEL
275 1PERGOLIDE MESYLATE
276 1PILOPEX 2 EYE DROPS
277 1PIOGLITAZONE HYDROCHLORIDE
278 1POTASSIUM CITRATE USP
279 1PRALATREXATE
280 1PRASUGREL HYDROCHLORIDE
281 1PRAVASTATIN SODIUM
282 1PREDNICARBATE DRUG SUBSTANCE
283 1PREGABALIN D9333
284 1PREGABALIN DRUG SUBSTANCE
285 1PROBENECID USP
286 1QUETIAPINE FUMARATE DRUG SUBSTANCE
287 1RALOXIFENE HYDROCHLORIDE
288 1RALOXIFENE HYDROCHLORIDE BULK DRUG SUBSTANCE
289 1RAMELTEON
290 1RASAGILINE MESYLATE
291 1RISEDRONATE SODIUM
292 1RISPERIDONE USP
293 1RIVAROXABAN
294 1ROCURONIUM BROMIDE
295 1ROMIDEPSIN
296 1ROSIGLITAZONE MALEATE
297 1ROSUVASTATIN CALCIUM (BULK)
298 1ROSUVASTATIN CALCIUM PROCESS G
299 1ROSUVASTATIN CALCIUM PROCESS G 2410
300 1ROTIGOTINE
301 1SACUBITRIL/VALSARTAN
302 1SAXAGLIPTIN MONOHYDRATE
303 1SD-809 DEUTETRABENAZINE
304 1SELEGILINE HYDROCHLORIDE
305 1SERTRALINE HYDROCHLORIDE
306 1SILDENAFIL CITRATE
307 1SILVER SULFADIAZINE
308 1SIMVASTATIN
309 1SIMVASTATIN (ETHANOL PROCESS)
310 2SITAGLIPTIN PHOSPHATE
311 1SITAGLIPTIN PHOSPHATE ENZYMATIC
312 1SODIUM ALENDRONATE
313 1SOFOSBUVIR 1213
314 1SOFOSBUVIR 1613
315 1SOLIFENACIN SUCCINATE
316 1SORAFENIB TOSYLATE
317 1SUGAMMADEX SODIUM
318 1SULFAMETHOXAZOLE
319 1SULFAMETHOXAZOLE USP
320 1SUNITINIB MALATE
321 1SYNTHETIC CONJUGATED ESTROGENS, A(F00375)
322 1TACROLIMUS
323 1TADALAFIL
324 1TAMOXIFEN CITRATE USP
325 1TELMISARTAN
326 1TERAZOSIN HCI 2H20
327 1TERAZOSIN HCI DIHYDRATE
328 1TERAZOSIN HYDROCHLORIDE
329 1TERBINAFINE HYDROCHLORIDE
330 1TERFENADINE
331 1TERGURIDE HYDROGENMALEATE
332 1TERIPARATIDE ACETATE
333 1THIOTEPA
334 1TICAGRELOR
335 1TICLOPIDINE HCL
336 1TIGECYCLINE
337 1TIMOLOL MALEATE
338 1TIOTROPIUM BROMIDE
339 1TOBRAMYCIN
340 1TOLTERODINE TARTRATE
341 2TORSEMIDE
342 1TRAZODONE HYDROCHLORIDE
343 1TRAZODONE HYDROCHLORIDE USP
344 1TRIAMCINOLONE ACETONIDE
345 1TRIAMCINOLONE ACETONIDE MICRONIZED STERILE
346 1TRIMETHOPRIM USP
347 1TRIMIPRAMINE MALEATE
348 1ULIPRISTAL ACETATE
349 1UMECLIDINIUM BROMIDE
350 1VALACYCLOVIR HYDROCHLORIDE
351 1VALRUBICIN (AD-32)
352 2VALSARTAN
353 1VECURONIUM BROMIDE
354 2VENLAFAXINE HYDROCHLORIDE
355 1VERAPAMIL HYDROCHLORIDE
356 1VILAZODONE HYDROCHLORIDE
357 1WARFARIN SODIUM CLATHRATE
358 1ZALEPLON
359 1ZIPRASIDONE HYDROCHLORIDE
360 1ZOLEDRONATE DISODIUM
361 1ZOLEDRONIC ACID
362 1ZOLMITRIPTAN
363 2ZOLPIDEM TARTRATE
364 1ZONISAMIDE
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-08
DMF Number : 3062
Submission : 1977-11-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-27
Pay. Date : 2014-10-22
DMF Number : 28764
Submission : 2014-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2833
Submission : 1977-01-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4040
Submission : 1980-12-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-04-04
DMF Number : 16144
Submission : 2002-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 24934
Submission : 2011-05-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14654
Submission : 1999-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12209
Submission : 1996-11-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20064
Submission : 2006-12-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-28
Pay. Date : 2017-01-10
DMF Number : 31302
Submission : 2017-01-12
Status : Active
Type : II
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