01 1Omega-3-Acid Ethyl Esters 90
02 1Sodium Butyrate
03 1Tripalmitolein
04 2Blank
01 1Active
02 2Inactive
03 2Blank
01 1Valid
02 1Withdrawn by Holder
03 3Blank
01 5Blank
01 5Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25223
Submission : 2011-12-20
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2005-213 - Rev 01
Issue Date : 2012-05-14
Type : Chemical
Substance Number : 1352
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2012-244 - Rev 00
Issue Date : 2013-10-23
Type : Chemical
Substance Number : 1250
Status : Withdrawn by Holder
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27128
Submission : 2013-07-22
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32849
Submission : 2018-06-26
Status : Inactive
Type : II
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