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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076792

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NDA 076792 describes METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Mylan, and Sun Pharm Inds, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; metoprolol tartrate. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
Summary for 076792
Tradename:METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Applicant:Mylan
Ingredient:hydrochlorothiazide; metoprolol tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076792
Ingredient-typeThiazides
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 076792
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 076792 ANDA Mylan Pharmaceuticals Inc. 0378-0424 N 0378-0424-01
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 076792 ANDA Mylan Pharmaceuticals Inc. 0378-0434 N 0378-0434-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;50MG
Approval Date:Aug 20, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Aug 20, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;100MG
Approval Date:Aug 20, 2004TE:ABRLD:No

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