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Last Updated: October 12, 2024

Details for New Drug Application (NDA): 075269


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NDA 075269 describes NIFEDIPINE, which is a drug marketed by Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Teva, Velzen Pharma Pvt, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Endo Operations, Martec Usa Llc, Norvium Bioscience, Novast Labs, Osmotica Pharm Us, Rising, Spil, Swiss Pharm, Twi Pharms, Valeant Pharms North, 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 075269
Tradename:NIFEDIPINE
Applicant:Valeant Pharms North
Ingredient:nifedipine
Patents:0
Pharmacology for NDA: 075269
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 075269
Suppliers and Packaging for NDA: 075269
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 075269 ANDA A-S Medication Solutions 50090-4234 50090-4234-0 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4234-0)
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 075269 ANDA A-S Medication Solutions 50090-4234 50090-4234-2 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4234-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Dec 4, 2000TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Dec 4, 2000TE:AB1RLD:No

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