Last Updated: September 29, 2026

Details for New Drug Application (NDA): 071812

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NDA 071812 describes METHYLDOPATE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Am Regent, Baxter Hlthcare, Hospira, Marsam Pharms Llc, Smith And Nephew, and Teva Parenteral, and is included in ten NDAs. Additional details are available on the METHYLDOPATE HYDROCHLORIDE profile page.

The generic ingredient in METHYLDOPATE HYDROCHLORIDE is methyldopate hydrochloride. There is one drug master file entry for this compound. Additional details are available on the methyldopate hydrochloride profile page.

Summary for 071812

Tradename:	METHYLDOPATE HYDROCHLORIDE
Applicant:	Marsam Pharms Llc
Ingredient:	methyldopate hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Dec 22, 1987	TE:		RLD:	No

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