Is there a generic for Ceftibuten dihydrate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Ceftibuten dihydrate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Ceftibuten dihydrate?

CEDAX (NDA 050686, BURKE THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ceftibuten dihydrate are approved?

Ceftibuten dihydrate is approved in the following dosage forms: capsule, for suspension.

FDA Orange Book · active-ingredient family

Ceftibuten dihydrate

Ceftibuten dihydrate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:CEDAX · NDA 050686

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, for suspension

Product	Applicant	Application	TE	Approved
CEDAXRLD×2	BURKE THERAP	NDA 050686	—	Dec 20, 1995
CEDAX	BURKE THERAP	NDA 050685	—	Dec 20, 1995

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ceftibuten dihydrate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo