Last Updated: November 9, 2026

Details for New Drug Application (NDA): 070192

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NDA 070192 describes METHYLDOPA, which is a drug marketed by Accord Hlthcare, Chartwell Rx, Duramed Pharms Barr, Halsey, Heritage Pharma, Parke Davis, Pliva, Purepac Pharm, Quagen, Rising, Roxane, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Par Pharm, Dava Pharms Inc, Ivax Sub Teva Pharms, Sandoz, Strides Pharma Intl, Abraxis Pharm, Am Regent, Baxter Hlthcare, Hospira, Marsam Pharms Llc, Smith And Nephew, and Teva Parenteral, and is included in ninety-six NDAs. It is available from two suppliers. Additional details are available on the METHYLDOPA profile page.

The generic ingredient in METHYLDOPA is methyldopate hydrochloride. There are four drug master file entries for this compound. Additional details are available on the methyldopate hydrochloride profile page.

Summary for 070192

Tradename:	METHYLDOPA
Applicant:	Roxane
Ingredient:	methyldopa
Patents:	0

Medical Subject Heading (MeSH) Categories for 070192

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents
Sympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	Apr 25, 1986	TE:		RLD:	No

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