Details for New Drug Application (NDA): 020496

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NDA 020496 describes AMARYL, 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 AMARYL profile page.

The generic ingredient in AMARYL is glimepiride. There are sixteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the glimepiride profile page.

Summary for 020496

Tradename:	AMARYL
Applicant:	Sanofi Aventis Us
Ingredient:	glimepiride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020496

Suppliers and Packaging for NDA: 020496

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMARYL	glimepiride	TABLET;ORAL	020496	NDA	Sanofi-Aventis U.S. LLC	0039-0221	0039-0221-10	100 TABLET in 1 BOTTLE (0039-0221-10)
AMARYL	glimepiride	TABLET;ORAL	020496	NDA	Sanofi-Aventis U.S. LLC	0039-0222	0039-0222-10	100 TABLET in 1 BOTTLE (0039-0222-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Nov 30, 1995	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Nov 30, 1995	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Nov 30, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020496

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-001	Nov 30, 1995	⤷ Try a Trial	⤷ Try a Trial
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-003	Nov 30, 1995	⤷ Try a Trial	⤷ Try a Trial
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-002	Nov 30, 1995	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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