Details for New Drug Application (NDA): 019982
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The generic ingredient in ZEBETA is bisoprolol fumarate. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate profile page.
Summary for 019982
Tradename: | ZEBETA |
Applicant: | Teva Womens |
Ingredient: | bisoprolol fumarate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 019982
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| DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Womens | ZEBETA | bisoprolol fumarate | TABLET;ORAL | 019982-001 | Jul 31, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Womens | ZEBETA | bisoprolol fumarate | TABLET;ORAL | 019982-002 | Jul 31, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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