Details for New Drug Application (NDA): 206801

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NDA 206801 describes PALONOSETRON HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Rx, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, and Hikma, and is included in twenty NDAs. It is available from thirteen suppliers. Additional details are available on the PALONOSETRON HYDROCHLORIDE profile page.

The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

Tradename:	PALONOSETRON HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	palonosetron hydrochloride
Patents:	0

Mechanism of Action	Serotonin 3 Receptor Antagonists

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	206801	ANDA	Fresenius Kabi USA, LLC	63323-673	63323-673-05	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-673-05) / 5 mL in 1 VIAL, SINGLE-DOSE
PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	206801	ANDA	Fresenius Kabi USA, LLC	63323-673	63323-673-89	10 SYRINGE, PLASTIC in 1 CARTON (63323-673-89) / 5 mL in 1 SYRINGE, PLASTIC (63323-673-21)

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date:	Sep 19, 2018	TE:	AP	RLD:	No

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