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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 090526

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NDA 090526 describes OXYBUTYNIN, which is a drug marketed by Barr Labs Div Teva, Chartwell Rx, Lannett Co Inc, Pharm Assoc, Pharmobedient Cnsltg, Accord Hlthcare, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Impax Pharms, Osmotica Pharm Us, Pharmobedient, Rubicon Research, Unique, Zydus Pharms, Abhai Llc, Aiping Pharm Inc, Avet Lifesciences, Hibrow Hlthcare, Leading, Novast Labs, Novitium Pharma, Quantum Pharmics, Regcon Holdings, Rising, Strides Pharma, Strides Pharma Intl, Teva Pharms Usa, Tp Anda Holdings, Usl Pharma, and Watson Labs, and is included in thirty-five NDAs. Additional details are available on the OXYBUTYNIN profile page.

The generic ingredient in OXYBUTYNIN is oxybutynin chloride. There are sixteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

Summary for 090526

Tradename:	OXYBUTYNIN
Applicant:	Barr Labs Div Teva
Ingredient:	oxybutynin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	3.9MG/24HR
Approval Date:	Mar 4, 2014	TE:		RLD:	No

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