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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 078050

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NDA 078050 describes ONDANSETRON, which is a drug marketed by Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Pharms Ltd, Ipca Labs Ltd, Nesher Pharms, Pharmobedient, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, 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, Sun Pharm Inds (in), Wockhardt Bio Ag, Amneal Pharms, Pharm Assoc, Taro, Apotex, Chartwell Rx, Dr Reddys Labs Ltd, Hikma Intl Pharms, Natco Pharma Ltd, and Taro Pharms Ireland, and is included in seventy-nine NDAs. It is available from thirty-one suppliers. Additional details are available on the ONDANSETRON profile page.

The generic ingredient in ONDANSETRON 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 078050

Tradename:	ONDANSETRON
Applicant:	Sandoz
Ingredient:	ondansetron
Patents:	0

Medical Subject Heading (MeSH) Categories for 078050

Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Serotonin Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	4MG
Approval Date:	Aug 13, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	8MG
Approval Date:	Aug 13, 2007	TE:	AB	RLD:	No

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