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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022524

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NDA 022524 describes ZUPLENZ, which is a drug marketed by Midatech Pharma Us and is included in one NDA. It is available from two suppliers. 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:Midatech Pharma Us
Ingredient:ondansetron
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022524
Medical Subject Heading (MeSH) Categories for 022524
Suppliers and Packaging for NDA: 022524
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZUPLENZ ondansetron FILM;ORAL 022524 NDA Galena Biopharma, Inc. 57881-444 57881-444-01 1 POUCH in 1 BOX (57881-444-01) > 1 FILM, SOLUBLE in 1 POUCH
ZUPLENZ ondansetron FILM;ORAL 022524 NDA Galena Biopharma, Inc. 57881-444 57881-444-10 10 POUCH in 1 BOX (57881-444-10) > 1 FILM, SOLUBLE in 1 POUCH

Profile for product number 001

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

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