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Details for New Drug Application (NDA): 077910

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NDA 077910 describes BISOPROLOL FUMARATE, which is a drug marketed by Aurobindo Pharma, Mylan, Unichem Pharms (usa), Sandoz, Teva Pharms, Frontida Biopharm, Unichem, Ivax Sub Teva Pharms, Apothecon, Watson Labs, Actavis Elizabeth, and Teva, and is included in fifteen NDAs. It is available from twelve suppliers. Additional details are available on the BISOPROLOL FUMARATE profile page.

The generic ingredient in BISOPROLOL FUMARATE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.

Summary for NDA: 077910

Tradename:
BISOPROLOL FUMARATE
Applicant:
Aurobindo Pharma
Ingredient:
bisoprolol fumarate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077910

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 077910

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE
bisoprolol fumarate
TABLET;ORAL 077910 ANDA Citron Pharma LLC 57237-132 57237-132-01 100 TABLET, FILM COATED in 1 BOTTLE (57237-132-01)
BISOPROLOL FUMARATE
bisoprolol fumarate
TABLET;ORAL 077910 ANDA Citron Pharma LLC 57237-132 57237-132-30 30 TABLET, FILM COATED in 1 BOTTLE (57237-132-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 27, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 27, 2006TE:ABRLD:No


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