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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Merck
Argus Health
Accenture
Julphar
Mallinckrodt
QuintilesIMS
Dow
Johnson and Johnson

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075643

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NDA 075643 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 075643
Tradename:BISOPROLOL FUMARATE
Applicant:Casi Pharms Inc
Ingredient:bisoprolol fumarate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075643
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 075643
Suppliers and Packaging for NDA: 075643
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 075643 ANDA Eon Labs, Inc. 0185-0771 N 0185-0771-01
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 075643 ANDA Eon Labs, Inc. 0185-0771 N 0185-0771-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 16, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 16, 2000TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Teva
Julphar
Deloitte
Chinese Patent Office
Healthtrust
Cipla
Fuji
Merck

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