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Generated: May 26, 2017

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Details for New Drug Application (NDA): 090756

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NDA 090756 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: 090756

Formulation / Manufacturing:see details

Pharmacology for NDA: 090756

Suppliers and Packaging for NDA: 090756

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:May 27, 2011TE:AARLD:No

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