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01 1BEMPEDOIC ACID
02 1BENZONATATE
03 1BRIVARACETAM
04 1BRIVARACETAM (PROCESS-II)
05 1DAPAGLIFLOZIN AMORPHOUS
06 1DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
07 1DAPRODUSTAT
08 1DESVENLAFAXINE
09 1DESVENLAFAXINE SUCCINATE
10 1DIACEREIN
11 1DICYCLOMINE HYDROCHLORIDE
12 1EDOXABAN TOSYLATE MONOHYDRATE
13 1EMPAGLIFLOZIN
14 1ESLICARBAZEPINE ACETATE
15 1FEBUXOSTAT
16 1FEZOLINETANT
17 1FINERENONE
18 1FINERENONE (PROCESS-II)
19 1FLUVOXAMINE MALEATE
20 1MIRABEGRON
21 1MIROGABALIN BESYLATE
22 1MIROGABALIN BESYLATE (PROCESS-II)
23 1OXCARBAZEPINE
24 1RESMETIROM
25 1RIVAROXABAN
26 1SACUBITRIL SODIUM
27 1SACUBITRIL VALSARTAN TRISODIUM SALT HEMIPENTAHYDRATE
28 1SEVELAMER CARBONATE
29 1SEVELAMER HYDROCHLORIDE
30 1SITAGLIPTIN PHOSPHATE MONOHYDRATE
31 1SITAGLIPTIN PHOSPHATE USP
32 1TADALAFIL
33 1TEGOPRAZAN (CRYSTALLINE)
34 1TOLVAPTAN
35 1TRANEXAMIC ACID USP
36 1VADADUSTAT
37 1VIBEGRON
38 1VONOPRAZAN FUMARATE
GDUFA
DMF Review : N/A
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DMF Number : 37511
Submission : 2022-10-03
Status : Active
Type : II
GDUFA
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DMF Number : 39002
Submission : 2023-12-04
Status : Active
Type : II
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DMF Number : 36655
Submission : 2022-01-08
Status : Active
Type : II
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Pay. Date :
DMF Number : 41918
Submission : 2025-05-30
Status : Active
Type : II
GDUFA
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DMF Number : 38009
Submission : 2023-02-23
Status : Active
Type : II
GDUFA
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DMF Number : 38010
Submission : 2023-02-23
Status : Active
Type : II
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DMF Number : 38516
Submission : 2023-06-30
Status : Active
Type : II
GDUFA
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DMF Number : 43978
Submission : 2026-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38066
Submission : 2023-03-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38766
Submission : 2023-09-15
Status : Active
Type : II
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