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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 070076


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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 Intl, 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 ActionAdrenergic 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. 64980-571 64980-571-01 100 TABLET in 1 BOTTLE (64980-571-01)
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:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 18, 1985TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Apr 18, 1985TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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