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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 202600


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NDA 202600 describes ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira, Onesource Specialty, Sandoz, Sun Pharm Inds Ltd, Taro Pharms Ireland, Teva, and Wockhardt Bio Ag, and is included in twenty NDAs. It is available from eleven 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-nine suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 202600
Tradename:ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Eugia Pharma
Ingredient:ondansetron hydrochloride
Patents:0
Pharmacology for NDA: 202600
Mechanism of ActionSerotonin 3 Receptor Antagonists
Suppliers and Packaging for NDA: 202600
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 202600 ANDA Eugia US LLC 55150-125 55150-125-02 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-125-02) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Dec 21, 2012TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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