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01 1ABROCITINIB
02 1ADAPALENE USP
03 1AVACOPAN
04 1BESIFLOXACIN HYDROCHLORIDE
05 1BRIMONIDINE TARTRATE USP
06 1CARBIDOPA USP
07 1CARBIMAZOLE
08 1CHLORTHALIDONE USP
09 1DAPOXETINE HYDROCHLORIDE
10 1DARIDOREXANT HYDROCHLORIDE
11 1DEUTETRABENAZINE
12 1DEXMEDETOMIDINE HYDROCHLORIDE USP
13 1DIBASIC POTASSIUM PHOSPHATE USP
14 1DIVALPROEX SODIUM USP
15 1DOCOSANOL
16 1DOXYCYCLINE HYCLATE USP
17 1DOXYCYCLINE MONOHYDRATE USP
18 1EFINACONAZOLE [ROUTE CODE 'EC']
19 1ESKETAMINE HYDROCHLORIDE
20 1FENFLURAMINE HYDROCHLORIDE
21 1FINERENONE
22 1FOSCARNET SODIUM USP
23 1GEMIFLOXACIN MESYLATE USP
24 1IPRAGLIFLOZIN L-PROLINE
25 1KETAMINE HYDROCHLORIDE USP
26 1LERCANIDIPINE HYDROCHLORIDE (AMORPHOUS)
27 1LERCANIDIPINE HYDROCHLORIDE (FORM-I)
28 1LEVODOPA USP
29 1LOMITAPIDE MESYLATE (FORM-M)
30 1LULICONAZOLE
31 1LUMACAFTOR
32 1MAGNESIUM SULFATE DRIED USP
33 1MANGANESE SULFATE MONOHYDRATE USP
34 1MARIBAVIR
35 1MAVACAMTEN
36 1MESALAMINE USP
37 1METHIMAZOLE USP
38 1MIRTAZAPINE ANHYDROUS USP
39 1MIRTAZAPINE USP [ROUTE CODE - MZ)
40 1MITAPIVAT SULFATE
41 1MONOBASIC SODIUM PHOSPHATE ANHYDROUS USP
42 1MONOBASIC SODIUM PHOSPHATE MONOHYDRATE USP
43 1NETARSUDIL DIMESYLATE
44 1NITROFURANTOIN ANHYDROUS USP
45 1NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS)
46 1NITROFURANTOIN HYDROUS USP
47 1OSPEMIFENE
48 1OZANIMOD HYDROCHLORIDE
49 1OZENOXACIN
50 1PENCICLOVIR
51 1POTASSIUM ACETATE USP
52 1POTASSIUM CHLORIDE USP
53 1POTASSIUM SULFATE
54 1RALTEGRAVIR POTASSIUM USP
55 1ROXADUSTAT
56 1SAPROPTERIN DIHYDROCHLORIDE
57 1SELENIOUS ACID USP
58 1SELEXIPAG (FORM-I)
59 1SELEXIPAG (FORM-III)
60 1SELEXIPAG (FORM-P)
61 1SIPONIMOD FUMARIC ACID
62 1SODIUM SULFATE ANHYDROUS USP
63 1TAPINAROF
64 1TIGECYCLINE USP (FORM-II) [ROUTE CODE 'TY']
65 1TRIFAROTENE
66 1TROSPIUM CHLORIDE USP
67 1VARENICLINE TARTRATE
68 1VERICIGUAT
69 2VILOXAZINE HYDROCHLORIDE
70 1VONOPRAZAN FUMARATE
71 1VORICONAZOLE CAMPHOR SULFONATE
72 1VORICONAZOLE USP
73 1XANOMELINE TARTRATE
74 1ZINC SULFATE HEPTAHYDRATE USP
75 1ZONISAMIDE USP
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41402
Submission : 2025-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39063
Submission : 2023-10-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2025-06-25
Pay. Date : 2025-05-20
DMF Number : 40159
Submission : 2024-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35809
Submission : 2021-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36595
Submission : 2021-12-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35521
Submission : 2020-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35808
Submission : 2021-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-09
Pay. Date : 2018-08-03
DMF Number : 32641
Submission : 2018-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34632
Submission : 2020-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42355
Submission : 2025-07-31
Status : Active
Type : II
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