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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
04/06/2025 Honour Lab
India
HONOUR LAB LTD 28627 NEBIVOLOL HYDROCHLORIDE 2014-09-10 Active II Complete 2015-01-05 2014-10-07
04/06/2025 Alkem Laboratories
India
ALKEM LABORATORIES LTD 39313 NEBIVOLOL HYDROCHLORIDE 2024-03-15 Active II Complete 2024-04-25 2024-04-12