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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

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. Thirty-two suppliers are listed for this compound. Additional details are available on the glyburide profile page.
Summary for 020051
Tradename:GLYNASE
Applicant:Pharmacia And Upjohn
Ingredient:glyburide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020051
Medical Subject Heading (MeSH) Categories for 020051
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)
Paragraph IV (Patent) Challenges for 020051
Tradename Dosage Ingredient NDA Submissiondate
GLYNASE TABLET;ORAL glyburide 020051

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.5MG
Approval Date:Mar 4, 1992TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Mar 4, 1992TE:ABRLD:Yes

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:Yes

Expired US Patents for NDA 020051

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-004 Sep 24, 1993   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-003 Sep 24, 1993   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-002 Mar 4, 1992   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-001 Mar 4, 1992   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-001 Mar 4, 1992   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-001 Mar 4, 1992   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-002 Mar 4, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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