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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 1BOSENTAN MONOHYDRATE
11 1BRINZOLAMIDE (PROCESS-II, STERILE)
12 1BRINZOLAMIDE USP (PROCESS-II)
13 1BRINZOLAMIDE USP (STERILE)
14 1BRINZOLAMIDE, USP
15 1CIPROFLOXACIN HYDROCHLORIDE USP
16 1CIPROFLOXACIN USP
17 1DABIGATRAN ETEXILATE MESYLATE (FORM-I)
18 1DAPAGLIFLOZIN PROPANEDIOL USP (MONOHYDRATE)
19 1DAPIPRAZOLE HYDROCHLORIDE
20 1DEFERASIROX
21 1DONEPEZIL BASE
22 1DONEPEZIL HYDROCHLORIDE USP (FORM-I)
23 1DORZOLAMIDE HYDROCHLORIDE FORM II USP
24 1DORZOLAMIDE HYDROCHLORIDE USP (PROCESS-II)
25 1EDARAVONE
26 1ELAGOLIX SODIUM
27 1ENALAPRIL MALEATE
28 1ENALAPRIL MALEATE USP
29 1ENTACAPONE USP (FORM-A)
30 1ESCITALOPRAM OXALATE
31 1ETHACRYNIC ACID USP
32 1EZETIMIBE USP (FORM-X)
33 1INDACATEROL MALEATE
34 1IPRATROPIUM BROMIDE USP
35 1ITRACONAZOLE USP
36 1LABETALOL HYDROCHLORIDE USP
37 1LEVETIRACETAM USP
38 1LEVOFLOXACIN USP (HEMIHYDRATE)
39 1LINEZOLID USP (FORM-II)
40 1LINEZOLID USP (PROCESS-II)
41 1LURASIDONE HYDROCHLORIDE
42 1MIRABEGRON
43 1MIRTAZAPINE
44 1MIRTAZAPINE USP (ACETONE ROUTE)
45 1MIRTAZAPINE, USP (ANHYDROUS)
46 1MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE USP
47 1OFLOXACIN USP
48 1OLANZAPINE FORM-1 USP
49 1PALIPERIDONE PALMITATE
50 1PALIPERIDONE PALMITATE STERILE
51 1PALONOSETRON HYDROCHLORIDE
52 1PARICALCITOL USP
53 1POSACONAZOLE
54 1PROPOFOL USP
55 1RAMIPRIL USP
56 1RIVAROXABAN
57 1ROPINIROLE
58 1ROPINIROLE HYDROCHLORIDE USP
59 1ROTIGOTINE USP
60 1SALMETEROL XINAFOATE USP
61 1SOTALOL HYDROCHLORIDE USP
62 1SUGAMMADEX SODIUM
63 1TAFAMIDIS (FORM-4)
64 1TAFAMIDIS MEGLUMINE
65 1TICAGRELOR FORM-II
66 1VILANTEROL TRIFENATATE
67 1VORICONAZOLE USP
68 1VOXELOTOR
69 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 : Complete
Rev. Date : 2015-10-13
Pay. Date : 2015-07-09
DMF Number : 26038
Submission : 2012-05-09
Status : Active
Type : II
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