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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216019

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NDA 216019 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, Pharmobedient, 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 216019

Tradename:	NIFEDIPINE
Applicant:	Swiss Pharm
Ingredient:	nifedipine
Patents:	0

Medical Subject Heading (MeSH) Categories for 216019

Calcium Channel Blockers
Tocolytic Agents
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	30MG
Approval Date:	Nov 18, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Nov 18, 2022	TE:		RLD:	No

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