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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090756

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NDA 090756 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 090756

Tradename:	CARBINOXAMINE MALEATE
Applicant:	Mission Pharmacal
Ingredient:	carbinoxamine maleate
Patents:	0

Pharmacology for NDA: 090756

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 090756

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	090756	ANDA	Biocomp Pharma, Inc.	44523-825	44523-825-01	1 BOTTLE in 1 CARTON (44523-825-01) / 100 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	May 27, 2011	TE:	AA	RLD:	No

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