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List of Drug Master Files (DMF) of NCGC00024676-03 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 Bayer AG
Germany
BAYER CORP 5905 BAYPRESS R(NITRENDIPINE)TABLETS 5MG.,10MG.AND 20MG. 1985-07-03 Inactive II N/A
26/09/2024 Bayer AG
Germany
BAYER CORP 5401 NITRENDIPINE, RAW MATERIAL SUB.(TM:BAYPRESS) 1984-06-18 Inactive II N/A