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Details for New Drug Application (NDA): 070076

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NDA 070076 describes METHYLDOPA, which is a drug marketed by Sandoz, Watson Labs, Teva, Duramed Pharms Barr, Pliva, Parke Davis, Par Pharm, Ivax Sub Teva Pharms, Purepac Pharm, Halsey, Sun Pharm Inds, Superpharm, Accord Hlthcare, Mylan, Roxane, Dava Pharms Inc, Marsam Pharms Llc, Smith And Nephew, Hospira, Abraxis Pharm, Teva Parenteral, Luitpold, and Baxter Hlthcare, 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 NDA: 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

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 0378-0421-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0421-01)
METHYLDOPA
methyldopa
TABLET;ORAL 070076 ANDA Mylan Pharmaceuticals Inc. 0378-0611 0378-0611-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0611-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 18, 1985TE:ABRLD:Yes

Summary for product number 002

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


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