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Last Updated: April 10, 2026

Details for New Drug Application (NDA): 091483

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NDA 091483 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 091483

Tradename:	ONDANSETRON HYDROCHLORIDE
Applicant:	Amneal Pharms
Ingredient:	ondansetron hydrochloride
Patents:	0

Pharmacology for NDA: 091483

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 091483

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	SOLUTION;ORAL	091483	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0691	17856-0691-1	1.5 mL in 1 SYRINGE (17856-0691-1)
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	SOLUTION;ORAL	091483	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0691	17856-0691-2	2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 4MG BASE/5ML
Approval Date:	Jan 31, 2011	TE:	AA	RLD:	No

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