01 1Gelatin Excipient
02 13Hard Capsule
01 1Active
02 13Blank
01 13Valid
02 1Blank
01 14Blank
01 14Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35867
Submission : 2021-04-23
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2001-332 - Rev 02
Issue Date : 2012-07-20
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2002-115 - Rev 02
Issue Date : 2012-07-20
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2009-395 - Rev 00
Issue Date : 2015-05-19
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2004-143 - Rev 02
Issue Date : 2012-06-12
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2000-067 - Rev 03
Issue Date : 2012-04-10
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2000-028 - Rev 02
Issue Date : 2012-04-12
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2000-044 - Rev 04
Issue Date : 2012-04-12
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2000-057 - Rev 03
Issue Date : 2012-04-12
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2003-083 - Rev 02
Issue Date : 2012-04-12
Type :
Substance Number :
Status : Valid
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