You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204010

✉ Email this page to a colleague

« Back to Dashboard

NDA 204010 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 204010

Tradename:	OXYBUTYNIN CHLORIDE
Applicant:	Amneal Pharms
Ingredient:	oxybutynin chloride
Patents:	0

Pharmacology for NDA: 204010

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 204010

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	204010	ANDA	Major Pharmaceuticals	0904-6570	0904-6570-04	30 BLISTER PACK in 1 CARTON (0904-6570-04) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	204010	ANDA	Major Pharmaceuticals	0904-6570	0904-6570-06	50 BLISTER PACK in 1 CARTON (0904-6570-06) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	Nov 23, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Nov 23, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	15MG
Approval Date:	Nov 23, 2015	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.