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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Chubb
Chinese Patent Office
Fish and Richardson
McKesson
Johnson and Johnson
Queensland Health
Cipla
McKinsey

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075831

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NDA 075831 describes BISOPROLOL FUMARATE, which is a drug marketed by Anda Repository, Aurobindo Pharma, Casi Pharms Inc, Mylan, Orit Labs Llc, Teva Pharms, Unichem Pharms (usa), Actavis Elizabeth, Apothecon, Ivax Sub Teva Pharms, Sandoz, Teva, Unichem, and Watson Labs Teva, and is included in sixteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 075831
Tradename:BISOPROLOL FUMARATE
Applicant:Mylan
Ingredient:bisoprolol fumarate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075831
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 075831
Suppliers and Packaging for NDA: 075831
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 075831 ANDA Mylan Pharmaceuticals Inc. 0378-0523 N 0378-0523-01
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 075831 ANDA Mylan Pharmaceuticals Inc. 0378-0523 N 0378-0523-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 14, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 14, 2005TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Accenture
Julphar
Johnson and Johnson
Deloitte
McKesson
Baxter
Teva

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