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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 022439


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NDA 022439 describes ZUTRIPRO, which is a drug marketed by Persion and is included in one NDA. Additional details are available on the ZUTRIPRO profile page.

The generic ingredient in ZUTRIPRO is chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.
Summary for 022439

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 8, 2011TE:RLD:Yes

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