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List of Drug Master Files (DMF) of Watson Brand of Triptorelin Embonate 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 Bachem AG
Switzerland
BACHEM AG 6291 TRIPTORELIN PAMOATE 1986-04-25 Active II N/A
26/09/2024 Debiopharm
Switzerland
DEBIOPHARM RESEARCH AND MANUFACTURING SA 30364 TRIPTORELIN PAMOATE MICROGRANULES 2016-03-11 Active II N/A