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01 1ABROCITINIB
02 1ADAPALENE USP
03 1AVACOPAN
04 1BESIFLOXACIN HYDROCHLORIDE
05 1BRIMONIDINE TARTRATE USP
06 1CARBIDOPA USP
07 1CARBIMAZOLE
08 1CENOBAMATE
09 1CHLORTHALIDONE USP
10 1DAPOXETINE HYDROCHLORIDE
11 1DARIDOREXANT HYDROCHLORIDE
12 1DEUTETRABENAZINE
13 1DEXMEDETOMIDINE HYDROCHLORIDE USP
14 1DIBASIC POTASSIUM PHOSPHATE USP
15 1DIVALPROEX SODIUM USP
16 1DOCOSANOL
17 1DOXYCYCLINE HYCLATE USP
18 1DOXYCYCLINE MONOHYDRATE USP
19 1EFINACONAZOLE [ROUTE CODE 'EC']
20 1ESKETAMINE HYDROCHLORIDE
21 1FENFLURAMINE HYDROCHLORIDE
22 1FINERENONE
23 1FOSCARNET SODIUM USP
24 1GEMIFLOXACIN MESYLATE USP
25 1IPRAGLIFLOZIN L-PROLINE
26 1IVACAFTOR
27 1KETAMINE HYDROCHLORIDE USP
28 1LERCANIDIPINE HYDROCHLORIDE (AMORPHOUS)
29 1LERCANIDIPINE HYDROCHLORIDE (FORM-I)
30 1LEVODOPA USP
31 1LOMITAPIDE MESYLATE (FORM-M)
32 1LULICONAZOLE
33 1LUMACAFTOR
34 1MAGNESIUM SULFATE DRIED USP
35 1MANGANESE SULFATE MONOHYDRATE USP
36 1MARIBAVIR
37 1MAVACAMTEN
38 1MESALAMINE USP
39 1METHIMAZOLE USP
40 1MIRTAZAPINE ANHYDROUS USP
41 1MIRTAZAPINE USP [ROUTE CODE - MZ)
42 1MITAPIVAT SULFATE
43 1MONOBASIC POTASSIUM PHOSPHATE USP
44 1NETARSUDIL DIMESYLATE
45 1NITROFURANTOIN ANHYDROUS USP
46 1NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS)
47 1NITROFURANTOIN HYDROUS USP
48 1OSPEMIFENE
49 1OZANIMOD HYDROCHLORIDE
50 1OZENOXACIN
51 1PENCICLOVIR
52 1POTASSIUM ACETATE USP
53 1POTASSIUM CHLORIDE USP
54 1POTASSIUM SULFATE
55 1RALTEGRAVIR POTASSIUM USP
56 1ROXADUSTAT
57 1SAPROPTERIN DIHYDROCHLORIDE
58 1SELENIOUS ACID USP
59 1SELEXIPAG (FORM-I)
60 1SELEXIPAG (FORM-III)
61 1SELEXIPAG (FORM-P)
62 1SIPONIMOD FUMARIC ACID
63 1SODIUM BICARBONATE USP
64 1SODIUM SULFATE ANHYDROUS USP
65 1TAPINAROF
66 1TIGECYCLINE USP (FORM-II) [ROUTE CODE 'TY']
67 1TRIFAROTENE
68 1TROSPIUM CHLORIDE USP
69 1VARENICLINE TARTRATE
70 1VERICIGUAT
71 2VILOXAZINE HYDROCHLORIDE
72 1VONOPRAZAN FUMARATE
73 1VORICONAZOLE CAMPHOR SULFONATE
74 1VORICONAZOLE USP
75 1XANOMELINE TARTRATE
76 1ZINC SULFATE HEPTAHYDRATE USP
77 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 : Complete
Rev. Date : 2026-03-13
Pay. Date : 2026-02-24
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 42901
Submission : 2025-11-04
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
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