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Generated: February 24, 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, Mylan, Orit Labs Llc, Sandoz, Teva Pharms, Unichem Pharms (usa), Actavis Elizabeth, Apothecon, Ivax Sub Teva Pharms, 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 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 Rebel Distributors Corp 21695-667 E 21695-667-90
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 078635 ANDA Rebel Distributors Corp 21695-667 E 21695-667-30

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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