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Serving hundreds of leading biopharmaceutical companies globally:

UBS
US Department of Justice
QuintilesIMS
Merck
Argus Health
Healthtrust
Medtronic
Federal Trade Commission
Accenture

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020403

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NDA 020403 describes ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER profile page.

The generic ingredient in ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER 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 020403
Tradename:ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
Applicant:Glaxosmithkline
Ingredient:ondansetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 31, 1995TE:RLD:Yes

Expired US Patents for NDA 020403

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER ondansetron hydrochloride INJECTABLE;INJECTION 020403-001 Jan 31, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER ondansetron hydrochloride INJECTABLE;INJECTION 020403-001 Jan 31, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER ondansetron hydrochloride INJECTABLE;INJECTION 020403-001 Jan 31, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Merck
US Department of Justice
Express Scripts
Julphar
Covington
US Army
Moodys
QuintilesIMS

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