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List of Drug Master Files (DMF) of Nebivolol HCl 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 Cadila Pharmaceuticals
India
CADILA PHARMACEUTICALS LTD 21152 NEBIVOLOL HYDROCHLORIDE 2007-12-08 Active II Complete 2014-03-25 2013-09-11
26/09/2024 CordenPharma
Germany
CORDEN PHARMA CHENOVE 30052 NEBIVOLOL HYDROCHLORIDE 2015-12-03 Active II N/A