Last Updated: November 13, 2026

Details for New Drug Application (NDA): 076656

NDA 076656 describes FENOLDOPAM MESYLATE, which is a drug marketed by Hikma, Luitpold, Sandoz, and Teva Parenteral, and is included in four NDAs. Additional details are available on the FENOLDOPAM MESYLATE profile page.

The generic ingredient in FENOLDOPAM MESYLATE is fenoldopam mesylate. There is one drug master file entry for this compound. Additional details are available on the fenoldopam mesylate profile page.

Summary for 076656

Tradename:	FENOLDOPAM MESYLATE
Applicant:	Luitpold
Ingredient:	fenoldopam mesylate
Patents:	0

Medical Subject Heading (MeSH) Categories for 076656

Antihypertensive Agents
Dopamine Agonists
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Dec 1, 2003	TE:		RLD:	No

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