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Serving leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
McKesson
Novartis
Harvard Business School
Merck
Cipla
Deloitte
Express Scripts
AstraZeneca

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020007

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NDA 020007 describes ZOFRAN PRESERVATIVE FREE, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. Additional details are available on the ZOFRAN PRESERVATIVE FREE profile page.

The generic ingredient in ZOFRAN PRESERVATIVE FREE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 020007
Tradename:ZOFRAN PRESERVATIVE FREE
Applicant:Novartis Pharms Corp
Ingredient:ondansetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 020007
Suppliers and Packaging for NDA: 020007
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007 NDA GlaxoSmithKline LLC 0173-0442 N 0173-0442-00
ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007 NDA GlaxoSmithKline LLC 0173-0442 N 0173-0442-00

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 4, 1991TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 10, 1993TE:RLD:Yes

Expired US Patents for NDA 020007

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Moodys
Medtronic
Merck
US Department of Justice
Chinese Patent Office
Accenture
QuintilesIMS
Harvard Business School

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