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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 021144

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NDA 021144 describes KETEK, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the KETEK profile page.

The generic ingredient in KETEK is telithromycin. Additional details are available on the telithromycin profile page.

Summary for 021144

Tradename:	KETEK
Applicant:	Sanofi Aventis Us
Ingredient:	telithromycin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Apr 1, 2004	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Feb 9, 2005	TE:		RLD:	No

Expired US Patents for NDA 021144

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-002	Feb 9, 2005	⤷ Get Started Free	⤷ Get Started Free
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004	⤷ Get Started Free	⤷ Get Started Free
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004	⤷ Get Started Free	⤷ Get Started Free
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-002	Feb 9, 2005	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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