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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 022524


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NDA 022524 describes ZUPLENZ, which is a drug marketed by Aquestive 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. Thirty-six suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
Summary for 022524
Tradename:ZUPLENZ
Applicant:Aquestive
Ingredient:ondansetron
Patents:2
Medical Subject Heading (MeSH) Categories for 022524

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FILM;ORALStrength4MG
Approval Date:Jul 2, 2010TE:RLD:Yes
Patent:8,580,830Patent Expiration:Nov 23, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:9,095,577Patent Expiration:Jul 13, 2030Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FILM;ORALStrength8MG
Approval Date:Jul 2, 2010TE:RLD:Yes
Patent:8,580,830Patent Expiration:Nov 23, 2029Product Flag?YSubstance Flag?Delist Request?

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