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List of Drug Master Files (DMF) of Goserelin acetate (JAN/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 Bachem AG
Switzerland
BACHEM AG 34363 GOSERELIN ACETATE 2019-12-19 Active II Complete 2020-03-12 2019-11-29
28/10/2024 Bachem AG
Switzerland
BACHEM AG 35689 GOSERELIN ACETATE 2024-05-07 Active II N/A