01 1Hard Fat
02 1Medium Chain Triglycerides Excipient
03 1Monooctanoin
04 4Blank
01 3Active
02 4Inactive
01 2Valid
02 5Blank
01 7Blank
01 7Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 800
Submission : 1964-05-07
Status : Active
Type : IV
Certificate Number : R1-CEP 2012-410 - Rev 00
Issue Date : 2019-02-11
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 35668
Submission : 2021-03-17
Status : Active
Type : IV
Certificate Number : CEP 2021-199 - Rev 00
Issue Date : 2023-10-09
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 420
Submission : 1960-12-07
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 7705
Submission : 1988-09-30
Status : Inactive
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10495
Submission : 1993-09-23
Status : Inactive
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 10524
Submission : 1993-10-12
Status : Inactive
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 10580
Submission : 1993-11-17
Status : Inactive
Type : IV
