Is there a generic for Oxybutynin?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Oxybutynin, referencing the brand OXYTROL FOR WOMEN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Oxybutynin?

OXYTROL FOR WOMEN (NDA 202211, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Oxybutynin are approved?

Oxybutynin is approved in the following dosage forms: film, extended release, gel, metered.

FDA Orange Book · active-ingredient family

Oxybutynin

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

Reference-listed drug:OXYTROL FOR WOMEN · NDA 202211

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · film, extended release, gel, metered

Product	Applicant	Application	TE	Approved
OXYTROL FOR WOMENRLD	ABBVIE	NDA 202211	—	Jan 25, 2013
GELNIQUE 3%RLD	ALLERGAN	NDA 202513	—	Dec 07, 2011
OXYTROLRLD	ALLERGAN	NDA 021351	—	Feb 26, 2003

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
OXYBUTYNIN	BARR LABS DIV TEVA	ANDA 090526	—	Mar 04, 2014

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.

Oxybutynin — frequently asked questions

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

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