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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077011

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NDA 077011 describes ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, 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. Seventy-five suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 077011
Applicant:West-ward Pharms Int
Ingredient:ondansetron hydrochloride
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Dec 26, 2006TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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Johnson and Johnson

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