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List of Drug Master Files (DMF) of Desogestrel 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 Aspen API
Netherlands
ASPEN OSS BV 7197 DESOGESTREL 1987-10-28 Active II Complete 2013-08-13 2013-08-01
26/09/2024 Symbiotec Pharmalab
India
SYMBIOTEC PHARMALAB PRIVATE LTD 28124 DESOGESTREL EP/BP, MICRONIZED 2014-03-17 Active II N/A