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List of Drug Master Files (DMF) of Adapalene 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
26/09/2024 Axplora
Germany
FINORGA SAS 8784 ADAPALENE 1990-10-12 Active II N/A
26/09/2024 Aarti Pharmalabs
India
AARTI PHARMALABS LTD 22709 ADAPALENE 2009-04-08 Active II Complete 2013-05-30 2013-05-21