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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 022524


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NDA 022524 describes ZUPLENZ, which is a drug marketed by Fortovia and is included in one NDA. There are two patents protecting this drug. Additional details are available on the ZUPLENZ profile page.

The generic ingredient in ZUPLENZ is ondansetron. There are twenty-eight drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
Summary for 022524
Tradename:ZUPLENZ
Applicant:Fortovia
Ingredient:ondansetron
Patents:2
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022524

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;ORALStrength4MG
Approval Date:Jul 2, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 23, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jul 13, 2030Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM;ORALStrength8MG
Approval Date:Jul 2, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 23, 2029Product Flag?YSubstance Flag?Delist Request?

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