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List of Drug Master Files (DMF) of Alphapharma Brand of Nitrazepam 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 Bausch Health
Canada
VALEANT PHARMACEUTICALS NORTH AMERICA 13151 MOGADON (NITRAZEPAM) TABLETS 1998-08-24 Inactive II N/A