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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
31/03/2026 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 25365 NISOLDIPINE 2011-10-07 Active II Complete 2014-09-23 2013-09-26
31/03/2026 Bayer AG
Germany
BAYER AG 10167 NISOLDIPINE 1993-03-31 Active II N/A