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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Boehringer Ingelheim
Chinese Patent Office
Daiichi Sankyo

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207768

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NDA 207768 describes TUZISTRA XR, which is a drug marketed by Vernalis R And D Ltd 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 TUZISTRA XR profile page.

The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.
Summary for 207768
Applicant:Vernalis R And D Ltd
Ingredient:chlorpheniramine polistirex; codeine polistirex
Formulation / Manufacturing:see details
Pharmacology for NDA: 207768
Suppliers and Packaging for NDA: 207768
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TUZISTRA XR chlorpheniramine polistirex; codeine polistirex SUSPENSION, EXTENDED RELEASE;ORAL 207768 NDA Vernalis Therapeutics, Inc. 69442-480 N 69442-480-20
TUZISTRA XR chlorpheniramine polistirex; codeine polistirex SUSPENSION, EXTENDED RELEASE;ORAL 207768 NDA Vernalis Therapeutics, Inc. 69442-480 N 69442-480-01

Profile for product number 001

Approval Date:Apr 30, 2015TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
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Fish and Richardson
Harvard Business School
Cantor Fitzgerald

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