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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022556

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NDA 022556 describes KARBINAL ER, which is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the KARBINAL ER profile page.

The generic ingredient in KARBINAL ER 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 022556
Tradename:KARBINAL ER
Applicant:Tris Pharma Inc
Ingredient:carbinoxamine maleate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022556
Suppliers and Packaging for NDA: 022556
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KARBINAL ER carbinoxamine maleate SUSPENSION, EXTENDED RELEASE;ORAL 022556 NDA Avadel Pharmaceuticals (USA), Inc. 13551-101 N 13551-101-05
KARBINAL ER carbinoxamine maleate SUSPENSION, EXTENDED RELEASE;ORAL 022556 NDA Avadel Pharmaceuticals (USA), Inc. 13551-101 N 13551-101-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;ORALStrength4MG/5ML
Approval Date:Mar 28, 2013TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jun 15, 2027Product Flag?YSubstance Flag?Delist Request?

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