Is there a generic for Floxuridine?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Floxuridine, referencing the brand FUDR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Floxuridine?

FUDR (NDA 016929, HOSPIRA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Floxuridine are approved?

Floxuridine is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Floxuridine

Floxuridine is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FUDR · NDA 016929

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
FUDRRLD	HOSPIRA	NDA 016929	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
FLOXURIDINE	AM REGENT	ANDA 203008	—	Nov 22, 2017
FLOXURIDINE	FRESENIUS KABI USA	ANDA 075837	AP	Feb 22, 2001
FLOXURIDINE	HIKMA	ANDA 075387	AP	Apr 16, 2000

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.

Floxuridine — frequently asked questions

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

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