Details for New Drug Application (NDA): 021204

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NDA 021204 describes STARLIX, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the STARLIX profile page.

The generic ingredient in STARLIX is nateglinide. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the nateglinide profile page.

Summary for 021204

Tradename:	STARLIX
Applicant:	Novartis
Ingredient:	nateglinide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 22, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 22, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021204

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000	6,844,008	⤷ Start Trial
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-001	Dec 22, 2000	5,463,116	⤷ Start Trial
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000	6,559,188	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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