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Serving leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
Federal Trade Commission

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070265

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NDA 070265 describes METHYLDOPA AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Dava Pharms Inc, Ivax Sub Teva Pharms, Mylan, Par Pharm, Parke Davis, Purepac Pharm, Sandoz, Teva, and Watson Labs, and is included in forty-three NDAs. It is available from one supplier. Additional details are available on the METHYLDOPA AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in METHYLDOPA AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; methyldopa. There are thirty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydrochlorothiazide; methyldopa profile page.
Summary for 070265
Ingredient:hydrochlorothiazide; methyldopa
Formulation / Manufacturing:see details
Pharmacology for NDA: 070265
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 070265
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLDOPA AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; methyldopa TABLET;ORAL 070265 ANDA Mylan Pharmaceuticals Inc. 0378-0507 0378-0507-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0507-01)
METHYLDOPA AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; methyldopa TABLET;ORAL 070265 ANDA Mylan Pharmaceuticals Inc. 0378-0711 0378-0711-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0711-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;250MG
Approval Date:Jan 23, 1986TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG;250MG
Approval Date:Jan 23, 1986TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
US Army
Queensland Health
US Department of Justice

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