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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
Harvard Business School
Farmers Insurance
Federal Trade Commission

Generated: February 25, 2018

DrugPatentWatch Database Preview

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-eight suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
Summary for 020103
Applicant:Novartis Pharms Corp
Ingredient:ondansetron hydrochloride
Therapeutic Class:Antiemetics
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 0078-0676 N 0078-0676-15
ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103 NDA GlaxoSmithKline LLC 0173-0446 N 0173-0446-00

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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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
US Army

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