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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 Midatech Pharma Us 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 ZUPLENZ profile page.

The generic ingredient in ZUPLENZ is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty-three suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the ondansetron profile page.

Summary for NDA: 022524

Tradename:
ZUPLENZ
Applicant:
Midatech Pharma Us
Ingredient:
ondansetron
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;ORALStrength4MG
Approval Date:Jul 2, 2010TE:RLD:No
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?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage: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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