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Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079032


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NDA 079032 describes ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Am Regent, Apotex Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Mylan Labs Ltd, Sandoz Inc, Sun Pharm Inds Ltd, Taro Pharms Ireland, Teva, West-ward Pharms Int, and Wockhardt, and is included in twenty NDAs. It is available from thirteen suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 079032
Tradename:ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Am Regent
Ingredient:ondansetron hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Nov 18, 2008TE:RLD:No

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Serving leading biopharmaceutical companies globally:

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