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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 203711

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NDA 203711 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Lannett Co Inc, Luitpold, Onesource Specialty, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Sandoz, Sun Pharm Inds (in), Teva, Wockhardt Bio Ag, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Chartwell Molecules, Chartwell Rx, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma Intl Pharms, Ipca Labs Ltd, Natco Pharma Ltd, Sun Pharm Inds Ltd, and Taro Pharms Ireland, and is included in sixty-eight NDAs. It is available from sixty-seven 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-nine suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for 203711

Tradename:	ONDANSETRON HYDROCHLORIDE
Applicant:	Qilu Pharm Hainan
Ingredient:	ondansetron hydrochloride
Patents:	0

Pharmacology for NDA: 203711

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 203711

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	203711	ANDA	Henry Schein, Inc.	0404-9930	0404-9930-02	1 VIAL, SINGLE-USE in 1 BAG (0404-9930-02) / 2 mL in 1 VIAL, SINGLE-USE
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	203711	ANDA	A-S Medication Solutions	50090-4935	50090-4935-0	25 VIAL, SINGLE-USE in 1 CARTON (50090-4935-0) / 2 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2MG BASE/ML
Approval Date:	Sep 8, 2014	TE:	AP	RLD:	No

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