Product Details for NDA 019982
ZEBETA (BISOPROLOL FUMARATE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BISOPROLOL FUMARATE
Proprietary Name: ZEBETA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019982
Product Number: 002
Approval Date: Jul 31, 1992
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZEBETA (BISOPROLOL FUMARATE)
Proprietary Name: ZEBETA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019982
Product Number: 002
Approval Date: Jul 31, 1992
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BISOPROLOL FUMARATE
Proprietary Name: ZEBETA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019982
Product Number: 001
Approval Date: Jul 31, 1992
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZEBETA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019982
Product Number: 001
Approval Date: Jul 31, 1992
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status: Discontinued
Patent and Exclusivity Information