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01 1Acetylcysteine
02 2Carbidopa
03 1Celecoxib
04 1Duloxetine Hydrochloride
05 1Esomeprazole Magnesium
06 1Fenofibrate
07 1Gabapentin
08 1Levodopa
09 1Methyldopa
10 1Metoprolol Succinate
11 1Metoprolol Tartrate
12 2Rosuvastatin Calcium
13 4Sitagliptin Phosphate
14 1Blank
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01 18Active
02 1Blank
01 7Valid
02 12Blank
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-02
Pay. Date : 2023-12-05
DMF Number : 37757
Submission : 2023-12-19
Status : Active
Type : II
Certificate Number : CEP 2024-034 - Rev 00
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 755
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-01
Pay. Date : 2023-12-05
DMF Number : 37758
Submission : 2023-11-17
Status : Active
Type : II
Certificate Number : CEP 2024-003 - Rev 00
Issue Date : 2024-03-19
Type : Chemical
Substance Number : 755
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-18
Pay. Date : 2016-09-23
DMF Number : 30174
Submission : 2016-03-07
Status : Active
Type : II
Certificate Number : R1-CEP 2016-142 - Rev 00
Issue Date : 2022-03-23
Type : Chemical
Substance Number : 2594
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-12-08
Pay. Date : 2022-11-03
DMF Number : 37243
Submission : 2022-10-31
Status : Active
Type : II
Certificate Number : CEP 2022-303 - Rev 01
Issue Date : 2026-03-19
Type : Chemical
Substance Number : 2173
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-11-04
Pay. Date : 2025-09-22
DMF Number : 40608
Submission : 2024-12-01
Status : Active
Type : II
Certificate Number : CEP 2024-527 - Rev 00
Issue Date : 2025-12-22
Type : Chemical
Substance Number : 38
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42829
Submission : 2025-12-05
Status : Active
Type : II
Certificate Number : CEP 2025-526 - Rev 00
Issue Date : 2026-01-21
Type : Chemical
Substance Number : 45
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2024-393 - Rev 00
Issue Date : 2025-11-05
Type : Chemical
Substance Number : 967
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31101
Submission : 2016-12-06
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-19
Pay. Date : 2016-09-29
DMF Number : 30901
Submission : 2016-09-15
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-11-23
Pay. Date : 2015-02-20
DMF Number : 28999
Submission : 2015-02-18
Status : Active
Type : II

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