Details for New Drug Application (NDA): 206416

NDA 206416 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, Meitheal, Mylan Institutional, Novast Labs, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, and Hikma, and is included in twenty NDAs. It is available from twenty suppliers. Additional details are available on the PALONOSETRON HYDROCHLORIDE profile page.

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

Summary for 206416

Tradename:	PALONOSETRON HYDROCHLORIDE
Applicant:	Mylan Institutional
Ingredient:	palonosetron hydrochloride
Patents:	0

Pharmacology for NDA: 206416

Mechanism of Action

Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 206416

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	206416	ANDA	Mylan Institutional LLC	67457-317	67457-317-25	1 VIAL, SINGLE-DOSE in 1 CARTON (67457-317-25) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

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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