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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070076

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NDA 070076 describes METHYLDOPA, which is a drug marketed by Accord Hlthcare, Duramed Pharms Barr, Halsey, Ivax Sub Teva Pharms, Mylan, Par Pharm, Parke Davis, Pliva, Purepac Pharm, Roxane, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Yaopharma Co Ltd, Dava Pharms Inc, Sandoz, Abraxis Pharm, Baxter Hlthcare, Hospira, Luitpold, Marsam Pharms Llc, Smith And Nephew, and Teva Parenteral, and is included in ninety-nine NDAs. It is available from ten 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. One supplier is listed for this compound. Additional details are available on the methyldopate hydrochloride profile page.
Summary for 070076
Tradename:METHYLDOPA
Applicant:Mylan
Ingredient:methyldopa
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 070076
Mechanism of ActionAdrenergic alpha2-Agonists
Medical Subject Heading (MeSH) Categories for 070076
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 Mylan Pharmaceuticals Inc. 0378-0421 N 0378-0421-01
METHYLDOPA methyldopa TABLET;ORAL 070076 ANDA Mylan Pharmaceuticals Inc. 0378-0611 N 0378-0611-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 18, 1985TE:ABRLD:No

Profile for product number 002

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

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