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Generated: November 20, 2017

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

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2
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 69442-480-01 473 mL in 1 BOTTLE (69442-480-01)
TUZISTRA XR
chlorpheniramine polistirex; codeine polistirex
SUSPENSION, EXTENDED RELEASE;ORAL 207768 NDA Vernalis Therapeutics, Inc. 69442-480 69442-480-20 25 mL in 1 BOTTLE (69442-480-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML
Approval Date:Apr 30, 2015TE:RLD:Yes
Patent:► SubscribePatent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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