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01 1ABROCITINIB
02 1ADAPALENE USP
03 1APIXABAN USP
04 1AVACOPAN
05 1BESIFLOXACIN HYDROCHLORIDE
06 1BRIMONIDINE TARTRATE USP
07 1CARBIDOPA USP
08 1CARBIMAZOLE
09 1CENOBAMATE
10 1CHLORTHALIDONE USP
11 1DAPOXETINE HYDROCHLORIDE
12 2DARIDOREXANT HYDROCHLORIDE
13 1DEUTETRABENAZINE
14 1DEXMEDETOMIDINE HYDROCHLORIDE USP
15 1DIBASIC POTASSIUM PHOSPHATE USP
16 1DIVALPROEX SODIUM USP
17 1DOCOSANOL
18 1DOXYCYCLINE HYCLATE USP
19 1DOXYCYCLINE MONOHYDRATE USP
20 1EFINACONAZOLE [ROUTE CODE 'EC']
21 1ELAFIBRANOR
22 1ESKETAMINE HYDROCHLORIDE
23 1FENFLURAMINE HYDROCHLORIDE
24 1FINERENONE
25 1FOSCARNET SODIUM USP
26 1GEMIFLOXACIN MESYLATE USP
27 1IPRAGLIFLOZIN L-PROLINE
28 1IVACAFTOR
29 1KETAMINE HYDROCHLORIDE USP
30 1LERCANIDIPINE HYDROCHLORIDE (AMORPHOUS)
31 1LERCANIDIPINE HYDROCHLORIDE (FORM-I)
32 1LEVODOPA USP
33 1LITHIUM CARBONATE USP
34 1LITHIUM CITRATE USP
35 1LOMITAPIDE MESYLATE (FORM-M)
36 1LULICONAZOLE
37 1LUMACAFTOR
38 1MAGNESIUM SULFATE DRIED USP
39 1MANGANESE SULFATE MONOHYDRATE USP
40 1MARIBAVIR
41 1MAVACAMTEN
42 1MESALAMINE USP
43 1METHIMAZOLE USP
44 1MIRTAZAPINE ANHYDROUS USP
45 1MIRTAZAPINE USP [ROUTE CODE - MZ)
46 1MITAPIVAT SULFATE
47 1MONOBASIC POTASSIUM PHOSPHATE USP
48 1NETARSUDIL DIMESYLATE
49 1NITROFURANTOIN ANHYDROUS USP
50 1NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS)
51 1NITROFURANTOIN HYDROUS USP
52 1OSPEMIFENE
53 1OZANIMOD HYDROCHLORIDE
54 1OZENOXACIN
55 1PENCICLOVIR
56 1POTASSIUM ACETATE USP
57 1POTASSIUM CHLORIDE USP
58 1POTASSIUM SULFATE
59 1RABEPRAZOLE SODIUM USP
60 1RALTEGRAVIR POTASSIUM USP
61 1REBAMIPIDE
62 1ROXADUSTAT
63 1SAPROPTERIN DIHYDROCHLORIDE
64 1SELENIOUS ACID USP
65 1SELEXIPAG (FORM-I)
66 1SELEXIPAG (FORM-III)
67 1SELEXIPAG (FORM-P)
68 1SIPONIMOD FUMARIC ACID
69 1SODIUM BICARBONATE USP
70 1SODIUM SULFATE ANHYDROUS USP
71 1SUVOREXANT
72 1TAPINAROF
73 1TIGECYCLINE USP (FORM-II) [ROUTE CODE 'TY']
74 1TRIFAROTENE
75 1TROSPIUM CHLORIDE USP
76 1VARENICLINE TARTRATE
77 1VERICIGUAT
78 2VILOXAZINE HYDROCHLORIDE
79 1VONOPRAZAN FUMARATE
80 1VORICONAZOLE CAMPHOR SULFONATE
81 1VORICONAZOLE USP
82 1XANOMELINE TARTRATE
83 1ZINC SULFATE HEPTAHYDRATE USP
84 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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