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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215476

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NDA 215476 describes CARBINOXAMINE MALEATE, which is a drug marketed by Cypress Pharm, Genus, Ph Health, Leading, Mikart, Mission Pharmacal, Senores Pharms, and Strides Pharma Intl, and is included in ten NDAs. It is available from seven suppliers. Additional details are available on the CARBINOXAMINE MALEATE profile page.

The generic ingredient in CARBINOXAMINE MALEATE is carbinoxamine maleate. There are seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.

Summary for 215476

Tradename:	CARBINOXAMINE MALEATE
Applicant:	Leading
Ingredient:	carbinoxamine maleate
Patents:	0

Pharmacology for NDA: 215476

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 215476

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	215476	ANDA	Leading Pharma, LLC	69315-239	69315-239-01	100 TABLET in 1 BOTTLE (69315-239-01)
CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	215476	ANDA	TRIPOINT THERAPEUTICS, LLC	80705-120	80705-120-30	30 TABLET in 1 BOTTLE (80705-120-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	6MG
Approval Date:	Dec 19, 2024	TE:	AA	RLD:	No

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