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Generated: May 22, 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, Watson Labs, and Yaopharma Co Ltd, 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-two 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
Tradename:METHYLDOPA AND HYDROCHLOROTHIAZIDE
Applicant:Mylan
Ingredient:hydrochlorothiazide; methyldopa
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070265
Ingredient-typeThiazides
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 N 0378-0507-01
METHYLDOPA AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; methyldopa TABLET;ORAL 070265 ANDA Mylan Pharmaceuticals Inc. 0378-0711 N 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 hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Johnson and Johnson
Cantor Fitzgerald
QuintilesIMS
Cipla
Dow
Daiichi Sankyo
Argus Health

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