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List of Drug Master Files (DMF) of Norethindrone 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 Sanofi
France
ROUSSEL CORP 1920 NORETHINDRONE 1972-04-17 Inactive II N/A
26/09/2024 Aspen API
Netherlands
ASPEN OSS BV 3849 NORETHINDRONE 1980-05-22 Active II Complete 2012-12-26 2012-11-20