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List of Drug Master Files (DMF) of Temazepam 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 Cambrex Corporation
U.S.A
CAMBREX PROFARMACO MILANO SRL 4376 TEMAZEPAM 1981-11-12 Active II Complete 2017-10-27 2017-10-16
26/09/2024 Centaur Pharmaceuticals
India
CENTAUR PHARMACEUTICALS PVT LTD 25364 TEMAZEPAM USP 2011-10-03 Inactive II N/A