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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 204891


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NDA 204891 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 204891
Tradename:BISOPROLOL FUMARATE
Applicant:Alembic
Ingredient:bisoprolol fumarate
Patents:0
Pharmacology for NDA: 204891
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 204891
Suppliers and Packaging for NDA: 204891
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 204891 ANDA Alembic Pharmaceuticals Limited 46708-603 46708-603-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-30)
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 204891 ANDA Alembic Pharmaceuticals Limited 46708-603 46708-603-31 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 11, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 11, 2017TE:ABRLD:No

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