Last Updated: May 3, 2026

Details for New Drug Application (NDA): 218303

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NDA 218303 describes BISOPROLOL FUMARATE, which is a drug marketed by Alembic, Aurobindo Pharma, Harman Finochem, Micro Labs, Natco Pharma Usa, Novitium Pharma, Prinston Inc, Rubicon Research, Teva Pharms, Tp Anda Holdings, Unichem, Unique Pharm, Zydus Lifesciences, Actavis Elizabeth, Apothecon, Aurobindo Pharma Ltd, 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-eight NDAs. It is available from twenty-three 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. Twelve suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.

Summary for 218303

Tradename:	BISOPROLOL FUMARATE
Applicant:	Micro Labs
Ingredient:	bisoprolol fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 218303

Adrenergic beta-1 Receptor Antagonists
Antihypertensive Agents
Sympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 9, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 9, 2026	TE:	AB	RLD:	No

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