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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 207138

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NDA 207138 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, Norvium Bioscience, Osmotica Pharm Us, Rubicon, Unique, Zydus Pharms, Abhai Llc, Avet Lifesciences, Beximco Pharms Usa, Hibrow Hlthcare, Leading, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Strides Pharma, Teva Pharms Usa, Trupharma, Upsher Smith Labs, Usl Pharma, and Watson Labs, and is included in thirty-four NDAs. It is available from thirty-nine 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. Forty suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

Summary for 207138

Tradename:	OXYBUTYNIN CHLORIDE
Applicant:	Accord Hlthcare
Ingredient:	oxybutynin chloride
Patents:	0

Pharmacology for NDA: 207138

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 207138

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	207138	ANDA	Accord Healthcare, Inc.	16729-317	16729-317-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-317-01)
OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	207138	ANDA	Accord Healthcare, Inc.	16729-317	16729-317-16	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-317-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	Feb 29, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Feb 29, 2016	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	15MG
Approval Date:	Feb 29, 2016	TE:	AB	RLD:	No

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