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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 090125

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NDA 090125 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Norvium Bioscience, Senores Pharms, Skg Pharma, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, Wockhardt, Inforlife, and Cipla, and is included in twenty-one 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-four suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for 090125

Tradename:	NICARDIPINE HYDROCHLORIDE
Applicant:	Navinta Llc
Ingredient:	nicardipine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 090125

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:	Nov 17, 2009	TE:		RLD:	No

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