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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 076183

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NDA 076183 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, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Sandoz, Steriscience Speclts, Sun Pharm Inds (in), Teva, Wockhardt, 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-five 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-seven suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for 076183

Tradename:	ONDANSETRON HYDROCHLORIDE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	ondansetron hydrochloride
Patents:	0

Pharmacology for NDA: 076183

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 076183

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	076183	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8185	0615-8185-00	5 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-00)
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	076183	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8185	0615-8185-05	15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 24MG BASE
Approval Date:	Dec 26, 2006	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 8MG BASE
Approval Date:	Dec 26, 2006	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Dec 26, 2006	TE:	AB	RLD:	No

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