01 1(+)-THREO-PHENYL-2-PIPERIDIN-2-YL-ACETIC ACID. HCI (5TC)
02 1(S)-3-(METHYLAMINO)-1-(2-THIENYL) PROPAN-1-OL [(S)-MMAA]
03 1ADENINE
04 1ALLOPURINOL
05 1ARTICAINE HYDROCHLORIDE DRUG SUBSTANCE
06 1ATOMOXETINE HYDROCHLORIDE
07 1BRINZOLAMIDE
08 1CANNABIDIOL
09 1CLINDAMYCIN PALMITATE HYDROCHLORIDE
10 1DIVALPROEX SODIUM
11 1DULOXETINE HYDROCHLORIDE
12 1DULOXETINE HYDROCHLORIDE (FROM (S)-MMAA-OME)
13 1ETHYL OLIVETOLATE (OL-COOET)
14 1HYDROXYCHLOROQUINE SULFATE
15 1LOXOPROFEN SODIUM DIHYDRATE
16 1MENTHADIENOL (PMDOL)
17 1OLIVETOL
18 1PROBUCOL
19 1PROPAFENONE HYDROCHLORIDE
20 1SODIUM VALPROATE
21 1THREO-PHENYL-2-PIPERIDIN-2-YL-ACETIC ACID (RITALINIC ACID)
22 1VALPROIC ACID
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25363
Submission : 2011-10-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27745
Submission : 2013-11-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37400
Submission : 2022-09-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24876
Submission : 2011-04-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11877
Submission : 1996-03-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-12
Pay. Date : 2020-11-09
DMF Number : 32363
Submission : 2018-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-20
Pay. Date : 2015-09-25
DMF Number : 29746
Submission : 2015-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-17
Pay. Date : 2020-09-29
DMF Number : 34635
Submission : 2020-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-30
Pay. Date : 2013-02-19
DMF Number : 24917
Submission : 2011-05-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-11-26
DMF Number : 18285
Submission : 2005-04-08
Status : Active
Type : II
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