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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 212798

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NDA 212798 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 212798

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

Pharmacology for NDA: 212798

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 212798

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	212798	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8492	0615-8492-05	15 TABLET in 1 BLISTER PACK (0615-8492-05)
OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	212798	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8492	0615-8492-39	30 TABLET in 1 BLISTER PACK (0615-8492-39)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 6, 2020	TE:	AB	RLD:	No

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