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01 1Glycerine
02 1Oleic Acid Chloride
03 1Blank
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01 1Active
02 2Blank
01 2Valid
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-02-03
Pay. Date : 2024-10-09
DMF Number : 40171
Submission : 2024-10-16
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2001-079 - Rev 02
Issue Date : 2011-04-19
Type : TSE
Substance Number : 799
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2024-360 - Rev 00
Issue Date : 2025-10-10
Type : TSE
Substance Number : 496
Status : Valid
