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01 1Doxycycline
02 2Doxycycline Hyclate
03 1Gentamicin Sulfate
04 1Obeticholic Acid
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01 1Active
02 3Inactive
03 1Blank
01 2Valid
02 3Blank
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01 5Blank
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01 5Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12864
Submission : 1998-02-17
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-038 - Rev 02
Issue Date : 2015-03-19
Type : Chemical
Substance Number : 272
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2012-243 - Rev 00
Issue Date : 2019-01-28
Type : Chemical
Substance Number : 820
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38348
Submission : 2023-05-04
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17094
Submission : 2004-01-14
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19916
Submission : 2006-08-31
Status : Inactive
Type : II