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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 074439

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NDA 074439 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Anda Repository, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Navinta Llc, Pharmobedient, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma, Hikma Intl Pharms, Mankind Pharma, Micro Labs, Nanjing King Friend, Qilu Pharm Hainan, Rk Pharma, Sun Pharm, Inforlife, Caplin, and Cipla, and is included in twenty-six NDAs. It is available from twenty-two suppliers. Additional details are available on the NICARDIPINE HYDROCHLORIDE profile page.

The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for 074439

Tradename:	NICARDIPINE HYDROCHLORIDE
Applicant:	Ani Pharms
Ingredient:	nicardipine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 074439

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	Dec 10, 1996	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Dec 10, 1996	TE:		RLD:	No

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