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01 2Amlodipine Besylate
02 3Atorvastatin
03 1Bacitracin Zinc
04 1Candesartan Cilexetil
05 1Carvedilol
06 1Chlortetracycline
07 1Clopidogrel
08 2Clopidogrel Hydrochloride
09 1Dabigatran Etexilate Mesylate
10 1Dapagliflozin
11 1Duloxetine Hydrochloride
12 2Enalapril Maleate
13 1Esomeprazole Magnesium
14 1Florfenicol
15 1Indapamide
16 1Lansoprazole
17 2Losartan Potassium
18 1Lovastatin
19 1Nifedipine
20 3Norfloxacin
21 1Olmesartan Medoxomil
22 2Oxytetracycline Dihydrate
23 1Pantoprazole Sodium
24 2Perindopril Erbumine
25 1Piroxicam
26 1Rabeprazole Sodium
27 2Rivaroxaban
28 2Rosuvastatin Calcium
29 2Simvastatin
30 3Telmisartan
31 1Ticagrelor
32 2Valsartan
33 1Venlafaxine Hydrochloride
34 1Blank
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01 7Inactive
02 43Blank
01 36Valid
02 7Withdrawn by Holder
03 7Blank
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01 50Blank
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01 15151
02 15879
03 48Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12809
Submission : 1997-12-29
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-212 - Rev 02
Issue Date : 2010-09-10
Type : Chemical
Substance Number : 1420
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2014-243 - Rev 01
Issue Date : 2021-05-11
Type : Chemical
Substance Number : 1491
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2022-449 - Rev 00
Issue Date : 2023-01-19
Type : Chemical
Substance Number : 1491
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2021-105 - Rev 01
Issue Date : 2022-01-28
Type : Chemical
Substance Number : 2191
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2013-024 - Rev 02
Issue Date : 2025-01-07
Type : Chemical
Substance Number : 2191
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-270 - Rev 03
Issue Date : 2025-04-25
Type : Chemical
Substance Number : 2191
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2016-132 - Rev 01
Issue Date : 2024-02-19
Type : Chemical
Substance Number : 2573
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2001-294 - Rev 04
Issue Date : 2015-01-28
Type : Chemical
Substance Number : 1745
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2014-027 - Rev 03
Issue Date : 2023-12-12
Type : Chemical
Substance Number : 2531
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2020-254 - Rev 02
Issue Date : 2025-12-16
Type : Chemical
Substance Number : 2791
Status : Valid

Krka is a supplier offers 36 products (APIs, Excipients or Intermediates).
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