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: 1 brand, 3 generics; first approved Aug 28, 2003; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 3 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

URISPAS

ORTHO MCNEIL JANSSENNDA 016769—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (3)

FLAVOXATE HYDROCHLORIDE

EPIC PHARMAANDA 0768352005

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Rx	AB

FLAVOXATE HYDROCHLORIDERS

PADAGIS USANDA 0768312004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Rx	AB

FLAVOXATE HYDROCHLORIDE

IMPAX PHARMSANDA 0762342003

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Aug 28, 2003

23 yr 2 mo ago

Most recent approval

Nov 30, 2005

20 yr 11 mo ago

Approvals span 2003–2005 across 4 FDA applications.

Brand (NDA) 125%

Generic (ANDA) 375%

Flavoxate hydrochloride — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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