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01 2Gelatin
02 1Gelatin Excipient
03 12Hard Capsule
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01 3Active
02 12Blank
01 11Valid
02 1Withdrawn by Holder
03 3Blank
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15547
Submission : 2001-07-15
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36561
Submission : 2021-12-02
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33090
Submission : 2018-10-12
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2005-217 - Rev 02
Issue Date : 2019-07-16
Type :
Substance Number :
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2015-262 - Rev 00
Issue Date : 2021-01-05
Type :
Substance Number :
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2010-356 - Rev 00
Issue Date : 2016-09-16
Type :
Substance Number :
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2024-475 - Rev 00
Issue Date : 2025-10-10
Type :
Substance Number :
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2010-004 - Rev 00
Issue Date : 2016-03-08
Type :
Substance Number :
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2000-344 - Rev 03
Issue Date : 2019-10-10
Type :
Substance Number :
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2013-087 - Rev 00
Issue Date : 2018-09-18
Type :
Substance Number :
Status : Valid
