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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 040458

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NDA 040458 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 040458

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

Pharmacology for NDA: 040458

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 040458

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBINOXAMINE MALEATE	carbinoxamine maleate	SOLUTION;ORAL	040458	ANDA	Genus Lifesciences Inc.	64950-243	64950-243-04	118 mL in 1 BOTTLE, PLASTIC (64950-243-04)
CARBINOXAMINE MALEATE	carbinoxamine maleate	SOLUTION;ORAL	040458	ANDA	Genus Lifesciences Inc.	64950-243	64950-243-16	473 mL in 1 BOTTLE, PLASTIC (64950-243-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	4MG/5ML
Approval Date:	Apr 25, 2003	TE:		RLD:	No

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