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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 SUCCINATE
09 1DIACEREIN
10 1DICYCLOMINE HYDROCHLORIDE
11 1EDOXABAN TOSYLATE MONOHYDRATE
12 1EMPAGLIFLOZIN
13 1ESLICARBAZEPINE ACETATE
14 1FEBUXOSTAT
15 1FINERENONE
16 1FINERENONE (PROCESS-II)
17 1MIRABEGRON
18 1MIROGABALIN BESYLATE
19 1MIROGABALIN BESYLATE (PROCESS-II)
20 1OXCARBAZEPINE
21 1RIVAROXABAN
22 1SACUBITRIL SODIUM
23 1SACUBITRIL VALSARTAN TRISODIUM SALT HEMIPENTAHYDRATE
24 1SEVELAMER CARBONATE
25 1SEVELAMER HYDROCHLORIDE
26 1SITAGLIPTIN PHOSPHATE MONOHYDRATE
27 1SITAGLIPTIN PHOSPHATE USP
28 1TADALAFIL
29 1TEGOPRAZAN (CRYSTALLINE)
30 1TOLVAPTAN
31 1TRANEXAMIC ACID USP
32 1VADADUSTAT
33 1VIBEGRON
34 1VONOPRAZAN FUMARATE
GDUFA
DMF Review : N/A
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DMF Number : 37511
Submission : 2022-10-03
Status : Active
Type : II
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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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DMF Number : 41918
Submission : 2025-05-30
Status : Active
Type : II
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DMF Number : 38009
Submission : 2023-02-23
Status : Active
Type : II
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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 : 38066
Submission : 2023-03-03
Status : Active
Type : II
GDUFA
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DMF Number : 38766
Submission : 2023-09-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40078
Submission : 2024-09-21
Status : Active
Type : II
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