You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
AstraZeneca
Merck
Mallinckrodt
McKinsey

Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206845


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 206845 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 206845
Tradename:ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Accord Hlthcare
Ingredient:ondansetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206845
Suppliers and Packaging for NDA: 206845
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 206845 ANDA Accord Healthcare, Inc. 16729-297 16729-297-83 5 VIAL in 1 CARTON (16729-297-83) > 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Mar 10, 2016TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt
McKesson
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.