01 15-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE)
02 1ADAPALENE
03 1BALSALAZIDE DISODIUM
04 1BECLOMETASONE DIPROPIONATE MONOHYDRATE MICRONIZED
05 1BECLOMETHASONE DIPROPIONATE
06 1BETAMETHASONE DIPROPIONATE MICRONIZED
07 1BETAMETHASONE VALERATE
08 1BUDESONIDE
09 1BUDESONIDE MICRONIZED STERILE
10 1BUSULFAN
11 1CANNABIDIOL
12 1CEFUROXIME SODIUM STERILE USP
13 1CELECOXIB USP
14 1CLOBETASOL PROPIONATE
15 1CLOCORTOLONE PIVALATE (MICRONIZED)
16 1CYPROTERONE ACETATE
17 1DELTA-1-CORTIENIC ACID
18 1DESONIDE DRUG SUBSTANCE
19 1DESOXIMETASONE
20 1DEXAMETHASONE USP
21 1DIFLUPREDNATE (MICRONIZED)
22 1EPOXIDE DESOXYMETASONE (INTERMEDIATE)
23 1ESMOLOL HYDROCHLORIDE
24 1EXEMESTANE MICRONIZED USP
25 1FLUDROCORTISONE ACETATE
26 1FLUMETHASONE
27 1FLUNISOLIDE ANHYDROUS USP
28 1FLUNISOLIDE HEMIHYDRATE (MICRONIZED)
29 1FLUOCINOLONE ACETONIDE
30 1FLUOCINONIDE, MICRONIZED BP/USP
31 1FLUOROMETHOLONE
32 1FLURANDRENOLIDE
33 1FLUTICASONE FUROATE
34 1FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED)
35 1FORMOTEROL FUMARATE
36 1FULVESTRANT
37 1HALCINONIDE
38 1HYDROCORTISONE HEMISUCCINATE
39 1ICOSAPENT ETHYL
40 1LOTEPREDNOL ETABONATE
41 1LOTEPREDNOL ETABONATE STERILE MICRONIZED
42 1MEDROXYPROGESTERONE ACETATE
43 1MEGESTROL ACETATE
44 1MELPHALAN HYDROCHLORIDE
45 1METHYLENE BLUE USP
46 1METHYLPREDNISOLONE ACETATE STERILE
47 1METHYLTESTOSTERONE (MICRONIZED)
48 1MIVACURIUM CHLORIDE
49 1MOMETASONE FUROATE
50 1MOMETASONE FUROATE (ALTERNATE PROCESS)
51 1N-ACETYL-L-CYSTEINE
52 1PACLITAXEL
53 1PROPAFENONE HYDROCHLORIDE
54 1SG-3249 (INTERMEDIATE DRUG LINKER)
55 1STERILE PREDNISOLONE-21-ACETATE MICRONIZED
56 1STERILIZED MEDROXYPROGESTERONE ACETATE USP (MICRONIZED)
57 1TERIFLUNOMIDE
58 1TIROFIBAN HYDROCHLORIDE MONOHYDRATE
59 1TRIAMCINOLONE ACETONIDE
60 1TRIAMCINOLONE ACETONIDE MICRONIZED STERILE
61 1TRIAMCINOLONE DIACETATE
62 1TRIAMCINOLONE HEXACETONIDE
63 1ZOLPIDEM TARTRATE MODIFIED SYNTHESIS
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 8070
Submission : 1989-05-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8784
Submission : 1990-10-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-10
Pay. Date : 2021-08-06
DMF Number : 16425
Submission : 2003-02-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21972
Submission : 2008-09-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-25
Pay. Date : 2019-04-22
DMF Number : 12813
Submission : 1998-01-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 23118
Submission : 2009-09-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-09
DMF Number : 12749
Submission : 1997-11-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-16
Pay. Date : 2013-05-03
DMF Number : 18910
Submission : 2005-10-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25615
Submission : 2011-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-08
Pay. Date : 2012-12-17
DMF Number : 25933
Submission : 2012-03-27
Status : Active
Type : II
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