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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 207484

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NDA 207484 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 207484

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

Pharmacology for NDA: 207484

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 207484

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	207484	ANDA	Carwin Pharmaceutical Associates, LLC	15370-130	15370-130-02	2 TABLET in 1 BOTTLE, PLASTIC (15370-130-02)
CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	207484	ANDA	Carwin Pharmaceutical Associates, LLC	15370-130	15370-130-10	100 TABLET in 1 BOTTLE, PLASTIC (15370-130-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	6MG
Approval Date:	May 31, 2016	TE:	AA	RLD:	No

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