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
d9d67fbc-c1c5-4cc3-aeab-92a6cd900e4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Athenex Pharmaceutical Division, LLC.
DUNS: 080318964
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 Code70860-785
Application NumberANDA202951
Product Classification
M
Marketing Category
C73584
G
Generic Name
palonosetron hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (8)
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULR
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
palonosetron hydrochlorideActive
Quantity: 0.05 mg in 1 mL
Code: 23310D4I19
Classification: ACTIM
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT