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Details for New Drug Application (NDA): 020051

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NDA 020051 describes GLYNASE, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from one supplier. Additional details are available on the GLYNASE profile page.

The generic ingredient in GLYNASE is glyburide. There are twenty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the glyburide profile page.

Summary for NDA: 020051

Tradename:
GLYNASE
Applicant:
Pharmacia And Upjohn
Ingredient:
glyburide
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 020051

Ingredient-typeSulfonylurea Compounds

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 and Upjohn Company LLC 0009-0341 0009-0341-01 100 TABLET in 1 BOTTLE, PLASTIC (0009-0341-01)
GLYNASE
glyburide
TABLET;ORAL 020051 NDA Pharmacia and Upjohn Company LLC 0009-0352 0009-0352-01 100 TABLET in 1 BOTTLE, PLASTIC (0009-0352-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.5MG
Approval Date:Mar 4, 1992TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Mar 4, 1992TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 24, 1993TE:RLD:No

Expired Orange Book Patents for NDA: 020051

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
GLYNASE
glyburide
TABLET;ORAL020051-002Mar 4, 19924,735,805► subscribe
Pharmacia And Upjohn
GLYNASE
glyburide
TABLET;ORAL020051-004Sep 24, 19934,735,805► subscribe
Pharmacia And Upjohn
GLYNASE
glyburide
TABLET;ORAL020051-001Mar 4, 19923,426,067► subscribe
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