Details for New Drug Application (NDA): 070076

NDA 070076 describes METHYLDOPA, which is a drug marketed by Accord Hlthcare, Chartwell Rx, Duramed Pharms Barr, Halsey, Heritage Pharma, Parke Davis, Pliva, Purepac Pharm, Rising, Roxane, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Par Pharm, Dava Pharms Inc, Ivax Sub Teva Pharms, Sandoz, Abraxis Pharm, Am Regent, Baxter Hlthcare, Hospira, Marsam Pharms Llc, Smith And Nephew, and Teva Parenteral, and is included in ninety-nine 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 three drug master file entries for this compound. Additional details are available on the methyldopate hydrochloride profile page.

Summary for 070076

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

Pharmacology for NDA: 070076

Mechanism of Action

Adrenergic alpha2-Agonists

Medical Subject Heading (MeSH) Categories for 070076

Adrenergic alpha-2 Receptor Agonists

Antihypertensive Agents

Sympatholytics

Suppliers and Packaging for NDA: 070076

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLDOPA	methyldopa	TABLET;ORAL	070076	ANDA	Rising Pharma Holdings, Inc.	64980-572	64980-572-01	100 TABLET in 1 BOTTLE (64980-572-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Apr 18, 1985	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Apr 18, 1985	TE:		RLD:	No

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