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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040442

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NDA 040442 describes CARBINOXAMINE MALEATE, which is a drug marketed by Vintage Pharms, Cypress Pharm, Invagen Pharms, Mikart, Mission Pharmacal Co, and Mikart Inc, and is included in nine 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. Eight suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.

Summary for NDA: 040442

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 040442

Suppliers and Packaging for NDA: 040442

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBINOXAMINE MALEATE
carbinoxamine maleate
TABLET;ORAL 040442 ANDA Mikart, Inc. 46672-191 46672-191-10 100 TABLET in 1 BOTTLE, PLASTIC (46672-191-10)
CARBINOXAMINE MALEATE
carbinoxamine maleate
TABLET;ORAL 040442 ANDA Mikart, Inc. 46672-191 46672-191-50 500 TABLET in 1 BOTTLE, PLASTIC (46672-191-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Mar 19, 2003TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Medtronic
Fish and Richardson
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Boehringer Ingelheim
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