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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 090671

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NDA 090671 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-one 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-five suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for 090671

Tradename:	NICARDIPINE HYDROCHLORIDE
Applicant:	Mankind Pharma
Ingredient:	nicardipine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 090671

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/10ML (2.5MG/ML)
Approval Date:	Nov 17, 2009	TE:	AP	RLD:	No

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