BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Farmers Insurance
US Army
Fish and Richardson
Queensland Health

Generated: January 18, 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 one supplier. 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. Seven suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.
Summary for 022556
Applicant:Tris Pharma Inc
Ingredient:carbinoxamine maleate
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 13551-101-01 2 BOTTLE, PLASTIC in 1 CARTON (13551-101-01) > 30 mL in 1 BOTTLE, PLASTIC
KARBINAL ER carbinoxamine maleate SUSPENSION, EXTENDED RELEASE;ORAL 022556 NDA Avadel Pharmaceuticals (USA), Inc. 13551-101 13551-101-05 480 mL in 1 BOTTLE, PLASTIC (13551-101-05)

Profile for product number 001

Approval Date:Mar 28, 2013TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:➤ SubscribePatent Expiration:Jun 15, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Argus Health
Federal Trade Commission
Boehringer Ingelheim
Cantor Fitzgerald

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