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Generated: May 27, 2019

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Details for New Drug Application (NDA): 020103

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NDA 020103 describes ZOFRAN, which is a drug marketed by Novartis Pharms Corp 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-six suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
Summary for 020103
Tradename:ZOFRAN
Applicant:Novartis Pharms Corp
Ingredient:ondansetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020103
Suppliers and Packaging for NDA: 020103
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103 NDA Novartis Pharmaceuticals Corporation 0078-0675 0078-0675-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0675-15)
ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103 NDA Novartis Pharmaceuticals Corporation 0078-0676 0078-0676-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0676-15)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Expired US Patents for NDA 020103

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