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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 215680


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NDA 215680 describes BISOPROLOL FUMARATE, which is a drug marketed by Alembic, Aurobindo Pharma, Dash Pharms Natco, Harman Finochem, Novitium Pharma, Prinston Inc, Rubicon, Teva Pharms, Trupharma, Unichem, Zydus Lifesciences, Actavis Elizabeth, Apothecon, Cadila, Chartwell Rx, Edenbridge Pharms, Epic Pharma Llc, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Mylan, Teva, and Watson Labs Teva, and is included in twenty-four NDAs. It is available from twenty-one 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. Thirteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 215680
Tradename:BISOPROLOL FUMARATE
Applicant:Zydus Lifesciences
Ingredient:bisoprolol fumarate
Patents:0
Pharmacology for NDA: 215680
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 215680
Suppliers and Packaging for NDA: 215680
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 215680 ANDA Zydus Lifesciences Limited 70771-1726 70771-1726-1 100 TABLET, FILM COATED in 1 BOTTLE (70771-1726-1)
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 215680 ANDA Zydus Lifesciences Limited 70771-1726 70771-1726-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1726-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 25, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 25, 2022TE:ABRLD:No

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