Last Updated: August 2, 2026

Details for New Drug Application (NDA): 073250

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NDA 073250 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, Martec Usa Llc, Novast Labs, Osmotica Pharm Us, Ph Health, Pharmadax, Pharmobedient, Rising, Spil, Twi Pharms, Valeant Pharms North, and Zydus Pharms, and is included in thirty NDAs. It is available from thirty-two 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-three suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for 073250

Tradename:	NIFEDIPINE
Applicant:	Velzen Pharma Pvt
Ingredient:	nifedipine
Patents:	0

Medical Subject Heading (MeSH) Categories for 073250

Calcium Channel Blockers
Tocolytic Agents
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Oct 8, 1991	TE:	AB	RLD:	No

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