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Last Updated: November 20, 2019

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Details for New Drug Application (NDA): 020605

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NDA 020605 describes ZOFRAN, which is a drug marketed by Novartis and Glaxosmithkline and is included in five NDAs. It is available from two suppliers. Additional details are available on the ZOFRAN profile page.

The generic ingredient in ZOFRAN is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
Summary for 020605
Tradename:ZOFRAN
Applicant:Novartis
Ingredient:ondansetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 020605
Tradename Dosage Ingredient NDA Submissiondate
ZOFRAN SOLUTION;ORAL ondansetron hydrochloride 020605 2004-12-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 4MG BASE/5ML
Approval Date:Jan 24, 1997TE:AARLD:Yes

Expired US Patents for NDA 020605

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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