Details for New Drug Application (NDA): 090713

NDA 090713 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 eighteen 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 suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

Summary for 090713

Tradename:	PALONOSETRON HYDROCHLORIDE
Applicant:	Teva Pharms Usa
Ingredient:	palonosetron hydrochloride
Patents:	0

Pharmacology for NDA: 090713

Mechanism of Action

Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 090713

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	090713	ANDA	Teva Parenteral Medicines, Inc.	0703-4094	0703-4094-01	1 VIAL, SINGLE-USE in 1 CARTON (0703-4094-01) / 5 mL in 1 VIAL, SINGLE-USE

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:	Mar 23, 2018	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
Approval Date:	Mar 23, 2018	TE:		RLD:	No

Complete Access Available with Subscription