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01 1APIXABAN P
02 1ATRACURIUM BESYLATE
03 1AZACITIDINE
04 1AZITHROMYCIN DIHYDRATE
05 1AZITHROMYCIN MONOHYDRATE
06 1AZITHROMYCIN N
07 1AZTREONAM USP
08 1BECLOMETHASONE DIPROPIONATE
09 1BELUMOSUDIL MESYLATE
10 1BETAMETHASONE ACETATE
11 1BETAMETHASONE DIPROPIONATE
12 1BETAMETHASONE VALERATE
13 1BICALUTAMIDE
14 1BIVALIRUDIN
15 1BLEOMYCIN SULFATE
16 1BORTEZOMIB
17 1BREXPIPRAZOLE
18 1BROMOCRIPTINE MESYLATE
19 2BUDESONIDE
20 1BUPRENORPHINE
21 1BUPRENORPHINE HYDROCHLORIDE
22 1BUTORPHANOL TARTRATE
23 1CABAZITAXEL
24 1CABERGOLINE
25 1CALCIPOTRIENE USP
26 1CALCITRIOL USP
27 1CARBIDOPA
28 1CARBIDOPA USP (DRUG SUBSTANCE)
29 1CARBOPLATIN
30 1CARFILZOMIB
31 1CARVEDILOL PHOSPHATE
32 1CARVEDILOL USP
33 1CASPOFUNGIN ACETATE
34 1CILOSTAZOL USP
35 1CINACALCET HYDROCHLORIDE
36 1CISATRACURIUM BESYLATE
37 1CLOBETASOL PROPIONATE
38 1CLOPIDOGREL BISULFATE USP
39 1CRISABOROLE
40 2CYCLOSPORINE
41 1CYCLOSPORINE ID: 741310
42 1CYCLOSPORINE ID: 741710
43 1DABIGATRAN ETEXILATE MESYLATE
44 1DASATINIB ANHYDROUS
45 1DASATINIB MONOHYDRATE
46 1DAUNORUBICIN HYDROCHLORIDE
47 1DEFERASIROX
48 1DEFEROXAMINE MESYLATE
49 1DESMOPRESSIN ACETATE USP
50 1DESONIDE
51 1DESVENLAFAXINE BASE
52 1DESVENLAFAXINE FUMARATE
53 1DESVENLAFAXINE SUCCINATE
54 1DIFLORASONE DIACETATE BULK DRUG
55 1DIFLUPREDNATE
56 1DIHYDROERGOTAMINE MESYLATE
57 1DILTIAZEM HYDROCHLORIDE USP
58 2DIMETHYL FUMARATE
59 1DIROXIMEL FUMARATE
60 1DOCETAXEL
61 1DONEPEZIL HYDROCHLORIDE
62 1DORZOLAMIDE HCL
63 1DOXEPIN HCL USP
64 1DOXORUBICIN HYDROCHLORIDE
65 1ELETRIPTAN HYDROBROMIDE
66 1EPIRUBICIN HYDROCHLORIDE LYOPHILIZED
67 1EPIRUBICIN HYDROCHLORIDE PRECIPITATED
68 1EPTIFIBATIDE
69 1ERGONOVINE MALEATE
70 1ERGOTAMINE TARTRATE
71 1ERLOTINIB HCL
72 1ESZOPICLONE ( PROCESS I )
73 1ESZOPICLONE (PROCESS II)
74 1ETOPOSIDE
75 1EZETIMIBE
76 1EZETIMIBE DRUG SUBSTANCE
77 1FAMCICLOVIR
78 1FEBUXOSTAT
79 1FINERENONE
80 1FINGOLIMOD HYDROCHLORIDE
81 1FLUDARABINE PHOSPHATE
82 1FLUNISOLIDE ANHYDROUS
83 1FLUNISOLIDE ANHYDROUS (NEW PROCESS)
84 1FLUOCINOLONE ACETONIDE (PROCESS I)
85 1FLUOCINOLONE ACETONIDE - PROCESS II
86 1FLUOCINONIDE
87 1FLUOCINONIDE (NEW PROCESS)
88 1FLUOROMETHOLONE-17-ACETATE
89 1FLUOXETINE HCI
90 1FLUTICASONE PROPIONATE
91 1FLUVASTATIN SODIUM
92 1FORMOTEROL FUMARATE DIHYDRATE
93 1FULVESTRANT
94 1GEMCITABINE HYDROCHLORIDE
95 1GEMCITABINE HYDROCHLORIDE (A-MESYLRIBOSE PROCESS)
96 1HALOPERIDOL
97 1HALOPERIDOL DECANOATE
98 2HYDROCHLOROTHIAZIDE
99 1IBRUTINIB
100 1ICATIBANT ACETATE
101 1IDARUBICIN HYDROCHLORIDE
102 1IMATINIB MESYLATE
103 1IMATINIB MESYLATE FORM ALPHA
104 1IMIPRAMINE HYDROCHLORIDE USP
105 1IRBESARTAN
106 1IRBESARTAN USP
107 1LAMOTRIGINE
108 1LETROZOLE
109 1LEVALBUTEROL HYDROCHLORIDE
110 1LEVOFLOXACIN
111 1LINACLOTIDE
112 1LOPERAMIDE HYDROCHLORIDE
113 2LOSARTAN POTASSIUM
114 1LOVASTATIN USP
115 1MACITENTAN
116 1MEDROXYPROGESTERONE ACETATE
117 1MEGESTROL ACETATE
118 1MEMANTINE HYDROCHLORIDE
119 1METHYLERGONOVINE MALEATE USP
120 1MICAFUNGIN SODIUM
121 1MITOMYCIN
122 1MOMETASONE FUROATE USP
123 2MONTELUKAST SODIUM
124 2MUPIROCIN
125 1MUPIROCIN CALCIUM
126 1MYCOPHENOLATE MOFETIL DRUG SUBSTANCE
127 1MYCOPHENOLATE SODIUM
128 1NIFEDIPINE
129 1NILOTINIB HYDROCHLORIDE
130 1NILOTINIB HYDROCHLORIDE FORM ALPHA
131 1OCTREOTIDE ACETATE
132 1OLANZAPINE FORM II
133 1OLANZAPINE USP
134 1OLMESARTAN MEDOXOMIL USP
135 1OMEPRAZOLE
136 1ONDANSETRON BASE
137 1ONDANSETRON HCL DIHYDRATE
138 1OXALIPLATIN
139 1PACLITAXEL
140 1PACLITAXEL SEMISYNTHETIC
141 1PACLITAXEL SEMISYNTHETIC (9-DHB)
142 1PACLITAXEL SEMISYNTHETIC (FROM 10-DAB)
143 1PACRITINIB CITRATE
144 1PALBOCICLIB
145 1PALIPERIDONE
146 1PALIPERIDONE PALMITATE STERILE
147 1PALONOSETRON HCL
148 1PALONOSETRON HYDROCHLORIDE
149 1PARICALCITOL USP
150 1PEMETREXED DIACID
151 1PERAMPANEL
152 1PIOGLITAZONE HYDROCHLORIDE
153 1POTASSIUM CITRATE USP
154 1PRALATREXATE
155 1PRASUGREL HYDROCHLORIDE
156 1PRAVASTATIN SODIUM
157 1PREDNICARBATE DRUG SUBSTANCE
158 1PREGABALIN D9333
159 1PREGABALIN DRUG SUBSTANCE
160 1PROBENECID USP
161 1QUETIAPINE FUMARATE
162 1RALOXIFENE HYDROCHLORIDE
163 1RAMELTEON
164 1RISEDRONATE SODIUM
165 1RISPERIDONE USP
166 1RIVAROXABAN
167 1ROCURONIUM BROMIDE
168 1ROMIDEPSIN
169 1ROSIGLITAZONE MALEATE
170 1ROSUVASTATIN CALCIUM (BULK)
171 1ROSUVASTATIN CALCIUM PROCESS G 2410
172 1ROTIGOTINE
173 1SACUBITRIL/VALSARTAN
174 1SAXAGLIPTIN MONOHYDRATE
175 1SD-809 DEUTETRABENAZINE
176 1SEMAGLUTIDE
177 1SILDENAFIL CITRATE
178 1SILVER SULFADIAZINE
179 1SIMVASTATIN
180 1SIMVASTATIN (ETHANOL PROCESS)
181 2SITAGLIPTIN PHOSPHATE
182 1SITAGLIPTIN PHOSPHATE ENZYMATIC
183 1SOFOSBUVIR 1213
184 1SOFOSBUVIR 1613
185 1SOLIFENACIN SUCCINATE
186 1SORAFENIB TOSYLATE
187 1SOTORASIB
188 1SUGAMMADEX SODIUM
189 1SUNITINIB MALATE
190 1TACROLIMUS
191 1TADALAFIL
192 1TAMOXIFEN CITRATE USP
193 1TAPINAROF
194 1TERAZOSIN HCI DIHYDRATE
195 1TERAZOSIN HYDROCHLORIDE
196 1TICAGRELOR
197 1TIGECYCLINE
198 1TIMOLOL MALEATE
199 1TIOTROPIUM BROMIDE
200 1TIRZEPATIDE
201 1TOBRAMYCIN
202 1TRAZODONE HYDROCHLORIDE USP
203 1TRIAMCINOLONE ACETONIDE
204 1ULIPRISTAL ACETATE
205 1UMECLIDINIUM BROMIDE
206 1VENLAFAXINE HYDROCHLORIDE
207 1VILAZODONE HYDROCHLORIDE
208 1WARFARIN SODIUM CLATHRATE
209 1ZOLEDRONIC ACID
210 1ZOLPIDEM TARTRATE
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41922
Submission : 2025-06-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-08-16
DMF Number : 11742
Submission : 1995-11-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-24
Pay. Date : 2012-11-13
DMF Number : 26126
Submission : 2012-06-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-13
Pay. Date : 2014-04-25
DMF Number : 15972
Submission : 2002-05-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15261
Submission : 2001-01-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-26
Pay. Date : 2012-11-13
DMF Number : 15985
Submission : 2002-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-12-03
DMF Number : 19342
Submission : 2006-04-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-31
Pay. Date : 2019-01-28
DMF Number : 4871
Submission : 1983-03-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41220
Submission : 2025-05-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-01
Pay. Date : 2016-03-04
DMF Number : 15327
Submission : 2001-03-01
Status : Active
Type : II
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