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Serving leading biopharmaceutical companies globally:

US Department of Justice
Covington
US Army
McKinsey
Federal Trade Commission
Accenture
Johnson and Johnson
Harvard Business School
Daiichi Sankyo
Mallinckrodt

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202253

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NDA 202253 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 fourteen 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-three suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 202253
Tradename:ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Fresenius Kabi Usa
Ingredient:ondansetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 202253
Suppliers and Packaging for NDA: 202253
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 202253 ANDA Fresenius Kabi USA, LLC 76045-103 N 76045-103-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Jul 19, 2013TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
US Department of Justice
Dow
Boehringer Ingelheim
AstraZeneca
Teva
QuintilesIMS
Johnson and Johnson

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