Details for New Drug Application (NDA): 020051

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NDA 020051 describes GLYNASE, which is a drug marketed by Pfizer and is included in one NDA. 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 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

Medical Subject Heading (MeSH) Categories for 020051

Hypoglycemic Agents

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DISCN	Dosage:	TABLET;ORAL			Strength	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-004	Sep 24, 1993	⤷ Sign Up	⤷ Sign Up
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-003	Sep 24, 1993	⤷ Sign Up	⤷ Sign Up
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	⤷ Sign Up	⤷ Sign Up
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992	⤷ Sign Up	⤷ Sign Up
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992	⤷ Sign Up	⤷ Sign Up
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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