Details for New Drug Application (NDA): 017532

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NDA 017532 describes DIABETA, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the DIABETA profile page.

The generic ingredient in DIABETA 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 017532

Tradename:	DIABETA
Applicant:	Sanofi Aventis Us
Ingredient:	glyburide
Patents:	0

Medical Subject Heading (MeSH) Categories for 017532

Hypoglycemic Agents

Suppliers and Packaging for NDA: 017532

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIABETA	glyburide	TABLET;ORAL	017532	NDA AUTHORIZED GENERIC	TEVA Pharmaceuticals USA Inc	0093-9364	0093-9364-01	100 TABLET in 1 BOTTLE (0093-9364-01)
DIABETA	glyburide	TABLET;ORAL	017532	NDA AUTHORIZED GENERIC	TEVA Pharmaceuticals USA Inc	0093-9364	0093-9364-05	500 TABLET in 1 BOTTLE (0093-9364-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1.25MG
Approval Date:	May 1, 1984	TE:	AB2	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	May 1, 1984	TE:	AB2	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 1, 1984	TE:	AB2	RLD:	Yes

Expired US Patents for NDA 017532

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-002	May 1, 1984	4,060,634	⤷ Subscribe
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984	3,507,961	⤷ Subscribe
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-001	May 1, 1984	4,060,634	⤷ Subscribe
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-002	May 1, 1984	3,507,961	⤷ Subscribe
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-001	May 1, 1984	3,426,067	⤷ Subscribe
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984	4,060,634	⤷ Subscribe
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