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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 209025

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NDA 209025 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 209025

Tradename:	OXYBUTYNIN CHLORIDE
Applicant:	Rising
Ingredient:	oxybutynin chloride
Patents:	0

Pharmacology for NDA: 209025

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 209025

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	209025	ANDA	A-S Medication Solutions	50090-6638	50090-6638-0	30 TABLET in 1 BOTTLE (50090-6638-0)
OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	209025	ANDA	A-S Medication Solutions	50090-6638	50090-6638-1	100 TABLET in 1 BOTTLE (50090-6638-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Dec 21, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Feb 7, 2023	TE:		RLD:	No

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