Details for New Drug Application (NDA): 019982

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NDA 019982 describes ZEBETA, which is a drug marketed by Teva Branded Pharm and is included in one NDA. Additional details are available on the ZEBETA profile page.

The generic ingredient in ZEBETA is bisoprolol fumarate. There are twelve drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate profile page.

Summary for 019982

Tradename:	ZEBETA
Applicant:	Teva Branded Pharm
Ingredient:	bisoprolol fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 019982

Adrenergic beta-1 Receptor Antagonists
Antihypertensive Agents
Sympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 31, 1992	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 31, 1992	TE:		RLD:	Yes

Expired US Patents for NDA 019982

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	ZEBETA	bisoprolol fumarate	TABLET;ORAL	019982-002	Jul 31, 1992	4,258,062*PED	⤷ Get Started Free
Teva Branded Pharm	ZEBETA	bisoprolol fumarate	TABLET;ORAL	019982-001	Jul 31, 1992	4,258,062*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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