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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210611

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NDA 210611 describes OXYBUTYNIN CHLORIDE, which is a drug marketed by 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-four NDAs. It is available from thirty-seven suppliers. Additional details are available on the OXYBUTYNIN CHLORIDE profile page.

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

Summary for 210611

Tradename:	OXYBUTYNIN CHLORIDE
Applicant:	Novast Labs
Ingredient:	oxybutynin chloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 30, 2019	TE:	AB	RLD:	No

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