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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 072974

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NDA 072974 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 are three drug master file entries for this compound. Additional details are available on the methyldopate hydrochloride profile page.

Summary for 072974

Tradename:	METHYLDOPATE HYDROCHLORIDE
Applicant:	Teva Parenteral
Ingredient:	methyldopate hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Nov 22, 1991	TE:		RLD:	No

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