01 14-PHENYLBUTYRIC ACID SODIUM SALT
02 1ACETYL SALICYLIC ACID (ASPIRIN USP)
03 1ACETYLSALICYLIC ACID (ASPIRIN USP)
04 1AMMONIUM LACTATE
05 1APRACLONIDINE HYDROCHLORIDE
06 1ARTICAINE HCL
07 1BACLOFEN
08 2CETIRIZINE DIHYDROCHLORIDE
09 1CICLOPIROX
10 1CILOSTAZOL
11 1CISATRACURIUM BESYLATE
12 1CISATRACURIUM BESYLATE PROCESS B
13 1CLASCOTERONE
14 1CLOMIPHENE CITRATE
15 1CLONIDINE BASE
16 1CLONIDINE HYDROCHLORIDE
17 1DALFAMPRIDINE
18 1DESIPRAMINE HCL
19 1DISOPYRAMIDE PHOSPHATE
20 1DISULFIRAM USP
21 1DIVALPROEX SODIUM
22 1EFINACONAZOLE
23 1ENCLOMIPHENE CITRATE
24 1ESOMEPRAZOLE SODIUM
25 1Estetrol Monohydrate
26 1FENOFIBRATE
27 1FLECAINIDE ACETATE USP
28 1FLUTICASONE FUROATE
29 1FLUTICASONE PROPIONATE
30 1FULVESTRANT
31 1GLYCOPYRROLATE
32 1GRANISETRON BASE
33 1GRANISETRON HYDROCHLORIDE
34 1HALOBETASOL PROPIONATE
35 1IMIQUIMOD
36 1KETAMINE HYDROCHLORIDE
37 1MEPIVACAINE HYDROCHLORIDE
38 1METHIMAZOLE
39 1MIDAZOLAM
40 1MIPRI
41 1MODAFINIL
42 1MOMETASONE FUROATE
43 1MOMETASONE FUROATE MONOHYDRATE
44 1OLOPATADINE HCL
45 1OXYBUTYNIN CHLORIDE USP
46 1PALONOSETRON HYDROCHLORIDE
47 1PCI-100250 NON-STERILE BULK DRUG
48 1PCI-101150 NON-STERILE BULK DRUG SUBSTANCE
49 1PCI-103101 NON-STERILE BULK DRUG SUBSTANCE
50 1PCI-104234 NON-STERILE BULK DRUG SUBSTANCE
51 1PCI-104400 NON-STERILE BULK DRUG SUBSTANCE
52 1PCI-104500 NON-STERILE BULK DRUG SUBSTANCE
53 1PCI-105551, NON-STERILE BULK DRUG SUBSTANCE
54 1PCI-114234
55 1PCI-PT6033 PODOPHYLLOTOXIN (NON-STERILE BULK DRUG SUBSTANCE)
56 1PERMETHRIN
57 1PHENYLACETIC ACID SODIUM SALT
58 1PODOPHYLLOTOXIN 184 NON-STERILE BULK DRUG SUBSTANCE
59 1PRALIDOXIME CHLORIDE
60 1PRAZIQUANTEL
61 1PYRIDOSTIGMINE BROMIDE USP
62 1RHODAPAP AND RHODAPAP DC PRODUCTS (ACETAMINOPHEN)
63 1ROCURONIUM BROMIDE
64 1ROLUPERIDONE HYDROCHLORIDE
65 1ROTIGOTINE
66 1S-KETAMINE HYDROCHLORIDE
67 1SITAGLIPTIN PHOSPHATE MONOHYDRATE
68 1SODIUM 4-PHENYLBUTYRATE
69 1SUGAMMADEX SODIUM
70 1TAZAROTENE
71 1TEMOZOLOMIDE
72 1TERAZOSIN HYDROCHLORIDE ANHYDROUS
73 1TIMOLOL HEMIHYDRATE
74 1TIMOLOL MALEATE
75 1TIMOLOL MALEATE (7125)
76 1TIOTROPIUM BROMIDE MONOHYDRATE
77 1TRAMADOL HYDROCHLORIDE
78 1TRIMEPRAZINE TARTRATE
79 1VALPROIC ACID
80 1ZUCLOMIPHENE CITRATE
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-12
Pay. Date : 2020-12-08
DMF Number : 9716
Submission : 1992-06-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-12
Pay. Date : 2013-01-18
DMF Number : 11373
Submission : 1995-03-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-12
Pay. Date : 2013-01-25
DMF Number : 12092
Submission : 1996-08-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-02
Pay. Date : 2023-10-30
DMF Number : 12003
Submission : 1996-06-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16601
Submission : 2003-05-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17935
Submission : 2004-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-09-30
DMF Number : 7077
Submission : 1987-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-05
Pay. Date : 2021-01-05
DMF Number : 35022
Submission : 2021-01-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-03
Pay. Date : 2017-02-08
DMF Number : 16244
Submission : 2002-11-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-30
DMF Number : 17007
Submission : 2003-12-01
Status : Active
Type : II
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