Is there a generic for Flavoxate hydrochloride?

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

What is the reference-listed drug for Flavoxate hydrochloride?

URISPAS (NDA 016769, ORTHO MCNEIL JANSSEN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Flavoxate hydrochloride are approved?

Flavoxate hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Flavoxate hydrochloride

Flavoxate hydrochloride 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:URISPAS · NDA 016769

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
URISPAS	ORTHO MCNEIL JANSSEN	NDA 016769	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
FLAVOXATE HYDROCHLORIDE	EPIC PHARMA	ANDA 076835	AB	Nov 30, 2005
FLAVOXATE HYDROCHLORIDE	PADAGIS US	ANDA 076831	AB	Dec 16, 2004
FLAVOXATE HYDROCHLORIDE	IMPAX PHARMS	ANDA 076234	—	Aug 28, 2003

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.

Flavoxate hydrochloride — frequently asked questions

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

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