ACTIVE SUBSTANCE / INN

OXYBUTYNIN

Brand name(s): GELNIQUE 3%, OXYTROL FOR WOMEN, Kentera (previously Oxybutynin Nicobrand), OXYTROL, OXYBUTYNIN

FDA LISTED

EMA LISTED

PRESCRIPTION

OVER-THE-COUNTER

DISCONTINUED

NDA021351

Urinary Incontinence, Urge

ACTIVE SUBSTANCE

Oxybutynin

REGULATORS

FDA · EMA

SPONSORS / MAH

Teva B.V. , ALLERGAN, BARR LABS DIV TEVA

TOTAL APPLICATIONS

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
OXYTROL FOR WOMEN	NDA202211	ABBVIE	Over-the-counter
GELNIQUE 3%	NDA202513	ALLERGAN	Discontinued
OXYBUTYNIN	ANDA090526	BARR LABS DIV TEVA	Discontinued
OXYTROL	NDA021351	ALLERGAN	Prescription

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Kentera (previously Oxybutynin Nicobrand)	Teva B.V.	Authorised	15/06/2004	Urinary Incontinence, Urge

FULL INTELLIGENCE ON OXYBUTYNIN