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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 018934


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NDA 018934 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 018934
Tradename:METHYLDOPA
Applicant:Chartwell Rx
Ingredient:methyldopa
Patents:0
Medical Subject Heading (MeSH) Categories for 018934
Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents
Sympatholytics
Suppliers and Packaging for NDA: 018934
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLDOPA methyldopa TABLET;ORAL 018934 NDA AUTHORIZED GENERIC Chartwell RX, LLC 62135-321 62135-321-18 180 TABLET, FILM COATED in 1 BOTTLE (62135-321-18)
METHYLDOPA methyldopa TABLET;ORAL 018934 NDA AUTHORIZED GENERIC Chartwell RX, LLC 62135-321 62135-321-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-321-90)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Jun 29, 1984TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Jun 29, 1984TE:RLD:No

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Preferred Citation:

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