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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 075414

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NDA 075414 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-six suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for 075414

Tradename:	NIFEDIPINE
Applicant:	Martec Usa Llc
Ingredient:	nifedipine
Patents:	0

Medical Subject Heading (MeSH) Categories for 075414

Calcium Channel Blockers
Tocolytic Agents
Vasodilator Agents

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	90MG
Approval Date:	Mar 23, 2004	TE:		RLD:	No

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