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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 NDA: 207768

Vernalis R And D Ltd
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
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)
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

Approval Date:Apr 30, 2015TE:RLD:Yes
Patent:8,062,667Patent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:8,790,700Patent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?

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