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Last Updated: August 10, 2022

Details for New Drug Application (NDA): 020103


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NDA 020103 describes ZOFRAN, which is a drug marketed by Novartis and Glaxosmithkline and is included in five NDAs. 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
Summary for 020103
Tradename:ZOFRAN
Applicant:Novartis
Ingredient:ondansetron hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Dec 31, 1992TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Dec 31, 1992TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 24MG BASE
Approval Date:Aug 27, 1999TE:RLD:Yes

Expired US Patents for NDA 020103

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999 See Plans and Pricing See Plans and Pricing
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992 See Plans and Pricing See Plans and Pricing
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-001 Dec 31, 1992 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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