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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Merck
Cantor Fitzgerald
AstraZeneca
Cipla
Citi
McKesson
UBS
Healthtrust

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078635

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NDA 078635 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 nine 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 078635
Tradename:BISOPROLOL FUMARATE
Applicant:Unichem Pharms (usa)
Ingredient:bisoprolol fumarate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078635
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 078635
Suppliers and Packaging for NDA: 078635
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 078635 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-126 N 29300-126-13
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 078635 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-126 N 29300-126-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 18, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 18, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Fish and Richardson
QuintilesIMS
Colorcon
US Army
UBS
Federal Trade Commission
Argus Health
Cerilliant

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