Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040458

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NDA 040458 describes CARBINOXAMINE MALEATE, which is a drug marketed by Cypress Pharm, Mikart, Vintage Pharms, Invagen Pharms, and Mission Pharmacal Co, and is included in nine NDAs. It is available from six 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. Seven suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.
Summary for 040458
Tradename:CARBINOXAMINE MALEATE
Applicant:Mikart
Ingredient:carbinoxamine maleate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040458
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 Mikart, Inc. 46672-644 46672-644-04 118 mL in 1 BOTTLE, PLASTIC (46672-644-04)
CARBINOXAMINE MALEATE carbinoxamine maleate SOLUTION;ORAL 040458 ANDA Mikart, Inc. 46672-644 46672-644-16 473 mL in 1 BOTTLE, PLASTIC (46672-644-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength4MG/5ML
Approval Date:Apr 25, 2003TE:RLD:No

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