Last Updated: August 11, 2026

Details for New Drug Application (NDA): 215406

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NDA 215406 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Navinta Llc, Pharmobedient, Senores Pharms, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma, Hikma Intl Pharms, Mankind Pharma, Micro Labs, Nanjing King Friend, Qilu Pharm Hainan, Somerset Theraps Llc, Sun Pharm, Inforlife, Caplin, and Cipla, and is included in twenty-six NDAs. It is available from twenty-five 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. Thirty suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for 215406

Tradename:	NICARDIPINE HYDROCHLORIDE
Applicant:	Amneal
Ingredient:	nicardipine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 215406

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	25MG/10ML (2.5MG/ML)
Approval Date:	Oct 31, 2024	TE:		RLD:	No

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