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List of Drug Master Files (DMF) of acidum azelaicum 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 Taro Pharmaceutical Industries
U.S.A
TARO PHARMACEUTICAL INDUSTRIES LTD 29484 AZELAIC ACID, MICRONIZED 2015-12-01 Active II Complete 2016-02-05 2015-11-30
26/09/2024 BASF
Germany
BASF SE 11615 DERMAZ 88 (AZELAIC ACID) 1995-08-04 Active II N/A