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Details for New Drug Application (NDA): 019982

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NDA 019982 describes ZEBETA, which is a drug marketed by Teva Womens and is included in one NDA. It is available from one supplier. 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. Thirteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate profile page.

Summary for NDA: 019982

Tradename:
ZEBETA
Applicant:
Teva Womens
Ingredient:
bisoprolol fumarate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019982

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 019982

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEBETA
bisoprolol fumarate
TABLET;ORAL 019982 NDA Teva Women's Health, Inc. 51285-061 51285-061-01 30 TABLET, FILM COATED in 1 BOTTLE (51285-061-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Jul 31, 1992TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Jul 31, 1992TE:RLD:No

Expired Orange Book Patents for NDA: 019982

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Womens
ZEBETA
bisoprolol fumarate
TABLET;ORAL019982-002Jul 31, 19924,258,062*PED► subscribe
Teva Womens
ZEBETA
bisoprolol fumarate
TABLET;ORAL019982-001Jul 31, 19924,258,062*PED► subscribe
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