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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 1MONOBASIC SODIUM PHOSPHATE ANHYDROUS USP
45 1MONOBASIC SODIUM PHOSPHATE MONOHYDRATE USP
46 1NETARSUDIL DIMESYLATE
47 1NITROFURANTOIN ANHYDROUS USP
48 1NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS)
49 1NITROFURANTOIN HYDROUS USP
50 1OSPEMIFENE
51 1OZANIMOD HYDROCHLORIDE
52 1OZENOXACIN
53 1PENCICLOVIR
54 1POTASSIUM ACETATE USP
55 1POTASSIUM CHLORIDE USP
56 1POTASSIUM SULFATE
57 1RALTEGRAVIR POTASSIUM USP
58 1ROXADUSTAT
59 1SAPROPTERIN DIHYDROCHLORIDE
60 1SELENIOUS ACID USP
61 1SELEXIPAG (FORM-I)
62 1SELEXIPAG (FORM-III)
63 1SELEXIPAG (FORM-P)
64 1SIPONIMOD FUMARIC ACID
65 1SODIUM BICARBONATE USP
66 1SODIUM SULFATE ANHYDROUS USP
67 1TAPINAROF
68 1TIGECYCLINE USP (FORM-II) [ROUTE CODE 'TY']
69 1TRIFAROTENE
70 1TROSPIUM CHLORIDE USP
71 1VARENICLINE TARTRATE
72 1VERICIGUAT
73 2VILOXAZINE HYDROCHLORIDE
74 1VONOPRAZAN FUMARATE
75 1VORICONAZOLE CAMPHOR SULFONATE
76 1VORICONAZOLE USP
77 1XANOMELINE TARTRATE
78 1ZINC SULFATE HEPTAHYDRATE USP
79 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 : 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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