Last Updated: June 9, 2026

Details for New Drug Application (NDA): 050686

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NDA 050686 describes CEDAX, which is a drug marketed by Burke Therap and is included in two NDAs. Additional details are available on the CEDAX profile page.

The generic ingredient in CEDAX is ceftibuten dihydrate. Additional details are available on the ceftibuten dihydrate profile page.

Summary for 050686

Tradename:	CEDAX
Applicant:	Burke Therap
Ingredient:	ceftibuten dihydrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 050686

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Burke Therap	CEDAX	ceftibuten dihydrate	FOR SUSPENSION;ORAL	050686-001	Dec 20, 1995	4,634,697	⤷ Start Trial
Burke Therap	CEDAX	ceftibuten dihydrate	FOR SUSPENSION;ORAL	050686-002	Dec 20, 1995	5,599,557	⤷ Start Trial
Burke Therap	CEDAX	ceftibuten dihydrate	FOR SUSPENSION;ORAL	050686-001	Dec 20, 1995	5,599,557	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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