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01 1ATORVASTATIN CALCIUM USP
02 1ATORVASTATIN CALCIUM USP (PROCESS II)
03 1BACLOFEN USP
04 1CILNIDIPINE
05 1CLOMIPRAMINE HYDROCHLORIDE USP
06 1CLOZAPINE USP
07 1EMPAGLIFLOZIN
08 1EMPAGLIFLOZIN (PROCESS II)
09 1HALOPERIDOL DECANOATE USP
10 1HALOPERIDOL USP
11 1MIDODRINE HYDROCHLORIDE USP
12 1NITROFURANTOIN MACROCRYSTALS USP
13 1NITROFURANTOIN MONOHYDRATE USP
14 1PANTOPRAZOLE SODIUM USP
15 1PANTOPRAZOLE SODIUM USP (PROCESS II)
16 1PROPRANOLOL HYDROCHLORIDE USP
17 1RANOLAZINE
18 1REVEFENACIN
19 1ROCURONIUM BROMIDE (NEU1017-I)
20 1ROCURONIUM BROMIDE USP
21 1ROSUVASTATIN CALCIUM USP
22 1SACUBITRIL SODIUM
23 1SACUBITRIL VALSARTAN TRISODIUM (AMORPHOUS)
24 1SITAGLIPTIN PHOSPHATE
25 1SUCCINYLCHOLINE CHLORIDE USP
26 1SUGAMMADEX SODIUM
27 1TELMISARTAN USP
28 1TICAGRELOR
29 1VALSARTAN DISODIUM
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-12
Pay. Date : 2021-11-29
DMF Number : 34844
Submission : 2020-06-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36365
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-21
Pay. Date : 2022-06-01
DMF Number : 37011
Submission : 2022-04-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39328
Submission : 2024-05-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-20
Pay. Date : 2020-07-21
DMF Number : 34935
Submission : 2020-07-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37540
Submission : 2023-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40847
Submission : 2025-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41404
Submission : 2025-02-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-30
Pay. Date : 2020-02-20
DMF Number : 34353
Submission : 2020-02-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-21
Pay. Date : 2019-11-14
DMF Number : 34190
Submission : 2019-11-22
Status : Active
Type : II
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