01 1ALBUTEROL SULFATE USP
02 1ALBUTEROL USP
03 1ALCAFTADINE
04 1APIXABAN
05 1APIXABAN (PROCESS-II)
06 1APREMILAST
07 1ARIPIPRAZOLE LAUROXIL
08 1ARIPIPRAZOLE MONOHYDRATE (STERILE)
09 1ARIPIPRAZOLE USP (ANHYDROUS FORM - B)
10 1BENZYL ALBUTEROL, INTERMEDIATE
11 1BOSENTAN MONOHYDRATE
12 1BRINZOLAMIDE (PROCESS-II, STERILE)
13 1BRINZOLAMIDE USP (PROCESS-II)
14 1BRINZOLAMIDE USP (STERILE)
15 1BRINZOLAMIDE, USP
16 1CIPROFLOXACIN HYDROCHLORIDE USP
17 1CIPROFLOXACIN USP
18 1DABIGATRAN ETEXILATE MESYLATE (FORM-I)
19 1DAPAGLIFLOZIN PROPANEDIOL USP (MONOHYDRATE)
20 1DAPIPRAZOLE HYDROCHLORIDE
21 1DEFERASIROX
22 1DONEPEZIL BASE
23 1DONEPEZIL HYDROCHLORIDE USP (FORM-I)
24 1DORZOLAMIDE HYDROCHLORIDE FORM II USP
25 1DORZOLAMIDE HYDROCHLORIDE USP (PROCESS-II)
26 1EDARAVONE
27 1ELAGOLIX SODIUM
28 1ENALAPRIL MALEATE
29 1ENALAPRIL MALEATE USP
30 1ENTACAPONE USP (FORM-A)
31 1ESCITALOPRAM OXALATE
32 1ETHACRYNIC ACID USP
33 1EZETIMIBE USP (FORM-X)
34 1INDACATEROL MALEATE
35 1IPRATROPIUM BROMIDE USP
36 1ITRACONAZOLE USP
37 1LABETALOL HYDROCHLORIDE USP
38 1LEVETIRACETAM USP
39 1LEVOFLOXACIN USP (HEMIHYDRATE)
40 1LINEZOLID USP (FORM-II)
41 1LINEZOLID USP (PROCESS-II)
42 1LURASIDONE HYDROCHLORIDE
43 1MIRABEGRON
44 1MIRTAZAPINE
45 1MIRTAZAPINE USP (ACETONE ROUTE)
46 1MIRTAZAPINE, USP (ANHYDROUS)
47 1MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE USP
48 1OFLOXACIN USP
49 1OLANZAPINE FORM-1 USP
50 1PALIPERIDONE PALMITATE
51 1PALIPERIDONE PALMITATE STERILE
52 1PALONOSETRON HYDROCHLORIDE
53 1PARICALCITOL USP
54 1POSACONAZOLE
55 1PROPOFOL USP
56 1RAMIPRIL USP
57 1RIVAROXABAN
58 1ROPINIROLE
59 1ROPINIROLE HYDROCHLORIDE USP
60 1ROTIGOTINE USP
61 1SALMETEROL XINAFOATE USP
62 1SOTALOL HYDROCHLORIDE USP
63 1SUGAMMADEX SODIUM
64 1TAFAMIDIS (FORM-4)
65 1TAFAMIDIS MEGLUMINE
66 1TICAGRELOR FORM-II
67 1VILANTEROL TRIFENATATE
68 1VORICONAZOLE USP
69 1VOXELOTOR
70 1VOXELOTOR ADIPIC ACID CO-CRYSTAL
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-26
Pay. Date : 2013-08-29
DMF Number : 16371
Submission : 2003-01-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16104
Submission : 2002-08-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-11-24
DMF Number : 28277
Submission : 2014-05-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-16
Pay. Date : 2018-06-13
DMF Number : 32422
Submission : 2018-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39444
Submission : 2024-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32953
Submission : 2018-11-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32683
Submission : 2018-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-26
Pay. Date : 2023-08-28
DMF Number : 36451
Submission : 2021-11-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-18
Pay. Date : 2021-08-10
DMF Number : 22889
Submission : 2009-06-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10253
Submission : 1993-05-12
Status : Active
Type : II
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