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01 15-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE)
02 1BALSALAZIDE DISODIUM
03 1BECLOMETASONE DIPROPIONATE MONOHYDRATE MICRONIZED
04 1BECLOMETHASONE DIPROPIONATE
05 1BETAMETHASONE DIPROPIONATE MICRONIZED
06 1BETAMETHASONE VALERATE
07 1BUDESONIDE
08 1BUDESONIDE MICRONIZED STERILE
09 1BUSULFAN
10 1CANNABIDIOL
11 1CEFUROXIME SODIUM STERILE USP
12 1CELECOXIB USP
13 1CLOBETASOL PROPIONATE
14 1CLOCORTOLONE PIVALATE (MICRONIZED)
15 1CYPROTERONE ACETATE
16 1DELTA-1-CORTIENIC ACID
17 1DESONIDE DRUG SUBSTANCE
18 1DESOXIMETASONE
19 1DEXAMETHASONE USP
20 1DIFLUPREDNATE (MICRONIZED)
21 1ESMOLOL HYDROCHLORIDE
22 1EXEMESTANE MICRONIZED USP
23 1FLUDROCORTISONE ACETATE
24 1FLUMETHASONE
25 1FLUNISOLIDE ANHYDROUS USP
26 1FLUNISOLIDE HEMIHYDRATE (MICRONIZED)
27 1FLUOCINOLONE ACETONIDE
28 1FLUOCINONIDE, MICRONIZED BP/USP
29 1FLUOROMETHOLONE
30 1FLURANDRENOLIDE
31 1FLUTICASONE FUROATE
32 1FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED)
33 1FORMOTEROL FUMARATE
34 1FULVESTRANT
35 1HALCINONIDE
36 1HYDROCORTISONE HEMISUCCINATE
37 1ICOSAPENT ETHYL
38 1LOTEPREDNOL ETABONATE
39 1LOTEPREDNOL ETABONATE STERILE MICRONIZED
40 1MEDROXYPROGESTERONE ACETATE
41 1MEGESTROL ACETATE
42 1MELPHALAN HYDROCHLORIDE
43 1METHYLENE BLUE USP
44 1METHYLPREDNISOLONE ACETATE STERILE
45 1METHYLTESTOSTERONE (MICRONIZED)
46 1MIVACURIUM CHLORIDE
47 1MOMETASONE FUROATE
48 1MOMETASONE FUROATE (ALTERNATE PROCESS)
49 1N-ACETYL-L-CYSTEINE
50 1PACLITAXEL
51 1PROPAFENONE HYDROCHLORIDE
52 1STERILE PREDNISOLONE-21-ACETATE MICRONIZED
53 1STERILIZED MEDROXYPROGESTERONE ACETATE USP (MICRONIZED)
54 1TERIFLUNOMIDE
55 1TIROFIBAN HYDROCHLORIDE MONOHYDRATE
56 1TRIAMCINOLONE ACETONIDE
57 1TRIAMCINOLONE ACETONIDE MICRONIZED STERILE
58 1TRIAMCINOLONE DIACETATE
59 1TRIAMCINOLONE HEXACETONIDE
60 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 : 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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34029
Submission : 2019-07-24
Status : Active
Type : II
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