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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078503

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NDA 078503 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 078503

Tradename:	OXYBUTYNIN CHLORIDE
Applicant:	Osmotica Pharm Us
Ingredient:	oxybutynin chloride
Patents:	0

Pharmacology for NDA: 078503

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 078503

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	078503	ANDA	AvKARE	42291-633	42291-633-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-633-01)
OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	078503	ANDA	AvKARE	42291-633	42291-633-50	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-633-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	Feb 4, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Feb 4, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	15MG
Approval Date:	Feb 4, 2009	TE:	AB	RLD:	No

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