Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Medtronic
AstraZeneca
McKesson
Harvard Business School

Last Updated: October 6, 2022

Details for New Drug Application (NDA): 020051


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


NDA 020051 describes GLYNASE, which is a drug marketed by Pfizer 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. Twenty-three 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
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)

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Pfizer GLYNASE glyburide TABLET;ORAL 020051-002 Mar 4, 1992 See Plans and Pricing See Plans and Pricing
Pfizer GLYNASE glyburide TABLET;ORAL 020051-001 Mar 4, 1992 See Plans and Pricing See Plans and Pricing
Pfizer GLYNASE glyburide TABLET;ORAL 020051-001 Mar 4, 1992 See Plans and Pricing See Plans and Pricing
Pfizer GLYNASE glyburide TABLET;ORAL 020051-002 Mar 4, 1992 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Colorcon
Medtronic
Harvard Business School
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.