Details for New Drug Application (NDA): 021178

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NDA 021178 describes GLUCOVANCE, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. Additional details are available on the GLUCOVANCE profile page.

The generic ingredient in GLUCOVANCE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.

Summary for 021178

Tradename:	GLUCOVANCE
Applicant:	Bristol Myers Squibb
Ingredient:	glyburide; metformin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1.25MG;250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 31, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 31, 2000	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 31, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021178

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-001	Jul 31, 2000	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-003	Jul 31, 2000	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-002	Jul 31, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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