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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Harvard Business School
Queensland Health
Dow
Julphar
Mallinckrodt
Fish and Richardson
Medtronic
Merck

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076974

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NDA 076974 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Lannett, Luitpold, Mylan Labs Ltd, Pliva Hrvatska Doo, Qilu Pharm Co Ltd, Sagent Pharms, Sandoz Inc, Sun Pharm Inds (in), Teva, West-ward Pharms Int, Wockhardt, Amneal Pharms, Apotex, Aurobindo Pharma, Silarx, Taro, Casi Pharms Inc, Chartwell Molecules, Dr Reddys Labs Ltd, Glenmark Generics, Hikma Intl Pharms, Ipca Labs Ltd, Mylan, Natco Pharma Ltd, Emcure Pharms Ltd, Sun Pharm Inds Ltd, and Taro Pharms Ireland, and is included in sixty-eight NDAs. It is available from sixty-three suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE profile page.

The generic ingredient in ONDANSETRON HYDROCHLORIDE 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 076974
Tradename:ONDANSETRON HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:ondansetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 076974
Suppliers and Packaging for NDA: 076974
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 076974 ANDA Fresenius Kabi USA, LLC 63323-374 N 63323-374-20

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:

Teva
UBS
Deloitte
Moodys
QuintilesIMS
Medtronic
US Department of Justice
McKesson
Dow

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