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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 1CELECOXIB USP
12 1CLOBETASOL PROPIONATE
13 1CLOCORTOLONE PIVALATE (MICRONIZED)
14 1CYPROTERONE ACETATE
15 1DELTA-1-CORTIENIC ACID
16 1DESONIDE DRUG SUBSTANCE
17 1DESOXIMETASONE
18 1DEXAMETHASONE USP
19 1DIFLUPREDNATE (MICRONIZED)
20 1ESMOLOL HYDROCHLORIDE
21 1EXEMESTANE MICRONIZED USP
22 1FLUDROCORTISONE ACETATE
23 1FLUMETHASONE
24 1FLUNISOLIDE ANHYDROUS USP
25 1FLUNISOLIDE HEMIHYDRATE (MICRONIZED)
26 1FLUOCINOLONE ACETONIDE
27 1FLUOCINONIDE, MICRONIZED BP/USP
28 1FLUOROMETHOLONE
29 1FLURANDRENOLIDE
30 1FLUTICASONE FUROATE
31 1FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED)
32 1FORMOTEROL FUMARATE
33 1FULVESTRANT
34 1HALCINONIDE
35 1HYDROCORTISONE HEMISUCCINATE
36 1ICOSAPENT ETHYL
37 1LOTEPREDNOL ETABONATE
38 1LOTEPREDNOL ETABONATE STERILE MICRONIZED
39 1MEDROXYPROGESTERONE ACETATE
40 1MEGESTROL ACETATE
41 1MELPHALAN HYDROCHLORIDE
42 1METHYLENE BLUE USP
43 1METHYLPREDNISOLONE ACETATE STERILE
44 1METHYLTESTOSTERONE (MICRONIZED)
45 1MIVACURIUM CHLORIDE
46 1MOMETASONE FUROATE
47 1MOMETASONE FUROATE (ALTERNATE PROCESS)
48 1N-ACETYL-L-CYSTEINE
49 1PACLITAXEL
50 1PROPAFENONE HYDROCHLORIDE
51 1STERILE PREDNISOLONE-21-ACETATE MICRONIZED
52 1STERILIZED MEDROXYPROGESTERONE ACETATE USP (MICRONIZED)
53 1TERIFLUNOMIDE
54 1TIROFIBAN HYDROCHLORIDE MONOHYDRATE
55 1TRIAMCINOLONE ACETONIDE
56 1TRIAMCINOLONE ACETONIDE MICRONIZED STERILE
57 1TRIAMCINOLONE DIACETATE
58 1TRIAMCINOLONE HEXACETONIDE
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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Axplora is your partner of choice for complex APIs.
