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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 1ESMOLOL HYDROCHLORIDE
23 1EXEMESTANE MICRONIZED USP
24 1FLUDROCORTISONE ACETATE
25 1FLUMETHASONE
26 1FLUNISOLIDE ANHYDROUS USP
27 1FLUNISOLIDE HEMIHYDRATE (MICRONIZED)
28 1FLUOCINOLONE ACETONIDE
29 1FLUOCINONIDE, MICRONIZED BP/USP
30 1FLUOROMETHOLONE
31 1FLURANDRENOLIDE
32 1FLUTICASONE FUROATE
33 1FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED)
34 1FORMOTEROL FUMARATE
35 1FULVESTRANT
36 1HALCINONIDE
37 1HYDROCORTISONE HEMISUCCINATE
38 1ICOSAPENT ETHYL
39 1LOTEPREDNOL ETABONATE
40 1LOTEPREDNOL ETABONATE STERILE MICRONIZED
41 1MEDROXYPROGESTERONE ACETATE
42 1MEGESTROL ACETATE
43 1MELPHALAN HYDROCHLORIDE
44 1METHYLENE BLUE USP
45 1METHYLPREDNISOLONE ACETATE STERILE
46 1METHYLTESTOSTERONE (MICRONIZED)
47 1MIVACURIUM CHLORIDE
48 1MOMETASONE FUROATE
49 1MOMETASONE FUROATE (ALTERNATE PROCESS)
50 1N-ACETYL-L-CYSTEINE
51 1PACLITAXEL
52 1PROPAFENONE HYDROCHLORIDE
53 1STERILE PREDNISOLONE-21-ACETATE MICRONIZED
54 1STERILIZED MEDROXYPROGESTERONE ACETATE USP (MICRONIZED)
55 1TERIFLUNOMIDE
56 1TIROFIBAN HYDROCHLORIDE MONOHYDRATE
57 1TRIAMCINOLONE ACETONIDE
58 1TRIAMCINOLONE ACETONIDE MICRONIZED STERILE
59 1TRIAMCINOLONE DIACETATE
60 1TRIAMCINOLONE HEXACETONIDE
61 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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