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Last Updated: August 11, 2020

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Details for New Drug Application (NDA): 075269

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NDA 075269 describes NIFEDIPINE, which is a drug marketed by Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Intergel Pharm, Leading Pharma Llc, Teva, Martec Usa Llc, Mylan, Mylan Labs Ltd, Novast Labs, Osmotica Pharm Us, Par Pharm, Spil, Twi Pharms, Valeant Pharms North, and Zydus Pharms, and is included in twenty-five NDAs. It is available from twenty-eight 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 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
Formulation / Manufacturing:see details
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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