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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 078539

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NDA 078539 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 078539

Tradename:	ONDANSETRON HYDROCHLORIDE
Applicant:	Aurobindo Pharma
Ingredient:	ondansetron hydrochloride
Patents:	0

Pharmacology for NDA: 078539

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 078539

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	078539	ANDA	NorthStar Rx LLC	16714-159	16714-159-01	30 TABLET, FILM COATED in 1 BOTTLE (16714-159-01)
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	078539	ANDA	NorthStar Rx LLC	16714-160	16714-160-01	30 TABLET, FILM COATED in 1 BOTTLE (16714-160-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Jul 31, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 8MG BASE
Approval Date:	Jul 31, 2007	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 24MG BASE
Approval Date:	Jul 31, 2007	TE:		RLD:	No

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