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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
AstraZeneca
Merck
Argus Health
Chubb
Teva
Boehringer Ingelheim
Medtronic
Covington

Generated: April 20, 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. 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-four 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

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2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 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:

US Army
Teva
Johnson and Johnson
Colorcon
Accenture
Medtronic
QuintilesIMS
Daiichi Sankyo
McKesson

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