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List of Drug Master Files (DMF) of Oxybutynin chloride [USAN:USP] Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
28/10/2024 Sanofi
France
SANOFI AVENTIS SPA 12840 OXYBUTYNIN CHLORIDE 1998-02-02 Inactive II N/A
28/10/2024 Seqens
France
PCAS 6412 OXYBUTYNIN CHLORIDE USP 1986-06-12 Active II Complete 2013-05-09 2013-04-30