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01 1Polysorbate 80
02 1Tween 20 Excipient
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01 1Inactive
02 1Blank
01 1Valid
02 1Withdrawn by Holder
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01 2Blank
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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 : 35475
Submission : 2020-12-21
Status : Inactive
Type : IV
Certificate Number : R0-CEP 2020-048 - Rev 00
Issue Date : 2020-09-04
Type :
Substance Number :
Status : Withdrawn by Holder
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-322 - Rev 00
Issue Date : 2025-03-17
Type :
Substance Number :
Status : Valid