Palonosetron Hydrochloride
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 2003
Approved
Approval ID
bb20ba9b-aa8c-4b24-8124-aff0cb6c956b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2018
Manufacturers
FDA
West-Ward Pharmaceuticals Corp
DUNS: 001230762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Palonosetron Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9513
Application NumberNDA207963
Product Classification
M
Marketing Category
C73594
G
Generic Name
Palonosetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (1)
PALONOSETRON HYDROCHLORIDEActive
Quantity: .25 mg in 2 mL
Code: 23310D4I19
Classification: ACTIM
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 10/13/2017