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Last Updated: July 13, 2024

Details for New Drug Application (NDA): 210838

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NDA 210838 describes NIFEDIPINE, which is a drug marketed by Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Leading, Teva, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Martec Usa Llc, Mylan, Novast Labs, Osmotica Pharm Us, Par Pharm, Rising, Spil, Twi Pharms, Valeant Pharms North, Vitruvias, and Zydus Pharms, and is included in thirty NDAs. It is available from thirty-five suppliers. Additional details are available on the NIFEDIPINE profile page.

The generic ingredient in NIFEDIPINE is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 210838
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 210838

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Apr 16, 2019TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Apr 16, 2019TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Apr 16, 2019TE:AB2RLD:No

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