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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 217617


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NDA 217617 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 217617
Tradename:BISOPROLOL FUMARATE
Applicant:Harman Finochem
Ingredient:bisoprolol fumarate
Patents:0
Pharmacology for NDA: 217617
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 217617
Suppliers and Packaging for NDA: 217617
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 217617 ANDA Sun Pharmaceutical Industries Limited 70095-019 70095-019-01 30 TABLET, FILM COATED in 1 BOTTLE, UNIT-DOSE (70095-019-01)
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 217617 ANDA Sun Pharmaceutical Industries Limited 70095-019 70095-019-02 100 TABLET, FILM COATED in 1 BOTTLE (70095-019-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 18, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 18, 2024TE:ABRLD:No

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