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-one suppliers are listed for this compound. Additional details are available on the glyburide profile page.
Summary for 020051
Tradename: | GLYNASE |
Applicant: | Pfizer |
Ingredient: | glyburide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020051
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYNASE | glyburide | TABLET;ORAL | 020051 | NDA | Pharmacia & Upjohn Company LLC | 0009-0352 | 0009-0352-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0009-0352-01) |
GLYNASE | glyburide | TABLET;ORAL | 020051 | NDA | Pharmacia & Upjohn Company LLC | 0009-0352 | 0009-0352-04 | 1000 TABLET in 1 BOTTLE, PLASTIC (0009-0352-04) |
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DISCN | Dosage: | TABLET;ORAL | Strength | 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | 020051-001 | Mar 4, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | GLYNASE | glyburide | TABLET;ORAL | 020051-004 | Sep 24, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | GLYNASE | glyburide | TABLET;ORAL | 020051-001 | Mar 4, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | GLYNASE | glyburide | TABLET;ORAL | 020051-003 | Sep 24, 1993 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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