Details for New Drug Application (NDA): 020051
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The generic ingredient in GLYNASE is glyburide. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the glyburide profile page.
Medical Subject Heading (MeSH) Categories for 020051
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
Approval Date: | Mar 4, 1992 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
Approval Date: | Mar 4, 1992 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Sep 24, 1993 | TE: | RLD: | Yes |
Expired US Patents for NDA 020051
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | GLYNASE | glyburide | TABLET;ORAL | 020051-002 | Mar 4, 1992 | 3,507,961 | ⤷ Subscribe |
Pfizer | GLYNASE | glyburide | TABLET;ORAL | 020051-003 | Sep 24, 1993 | 4,916,163 | ⤷ Subscribe |
Pfizer | GLYNASE | glyburide | TABLET;ORAL | 020051-001 | Mar 4, 1992 | 4,735,805 | ⤷ Subscribe |
Pfizer | GLYNASE | glyburide | TABLET;ORAL | 020051-002 | Mar 4, 1992 | 3,507,954 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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