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17 Apr 2026
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16 Apr 2026
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01 2Atorvastatin
02 1Baclofen
03 1Brivaracetam
04 1Cilnidipine
05 1Clomipramine Hydrochloride
06 1Clozapine
07 1Dydrogesterone
08 2Empagliflozin
09 1Ensifentrine
10 1Etoricoxib
11 1Fezolinetant
12 1Haloperidol
13 1Haloperidol Decanoate
14 1Lasmiditan
15 1Latanoprostene Bunod
16 1Lifitegrast
17 1Midodrine
18 1Netarsudil
19 1Netarsudil Mesylate
20 2Nitrofurantoin
21 1Obeticholic Acid
22 2Pantoprazole Sodium
23 1Perfluorohexyloctane
24 1Propranolol Hydrochloride
25 1Ranolazine
26 1Resmetirom
27 1Revefenacin
28 1Rocuronium Bromide
29 1Rosuvastatin Calcium
30 1Sacubitril Sodium
31 1Sacubitril-Valsartan
32 1Semaglutide
33 1Sitagliptin Phosphate
34 1Succinylcholine Chloride
35 1Sugammadex Sodium
36 1Suzetrigine
37 1Telmisartan
38 1Ticagrelor
39 1Upadacitinib
40 1Ursodeoxycholic Acid
41 1Valsartan
42 1Xanomeline
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01 30Active
02 16Blank
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01 1Su382-8-ND
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GDUFA
DMF Review : Reviewed
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 : Reviewed
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 : Reviewed
Rev. Date : 2020-08-20
Pay. Date : 2020-07-21
DMF Number : 34935
Submission : 2020-07-30
Status : Active
Type : II
| Available Reg. Filing : ASMF |
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
| Available Reg. Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41404
Submission : 2025-02-27
Status : Active
Type : II
| Available Reg. Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-01-21
Pay. Date : 2019-11-14
DMF Number : 34190
Submission : 2019-11-22
Status : Active
Type : II
| Available Reg. Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-30
Pay. Date : 2020-02-20
DMF Number : 34353
Submission : 2020-02-26
Status : Active
Type : II
| Available Reg. Filing : ASMF |
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