ALOXI
These highlights do not include all the information needed to use ALOXI CAPSULES safely and effectively. See full prescribing information for ALOXI CAPSULES. ALOXI (palonosetron HCl) capsules, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
ab89d423-4275-4651-9ae7-9002f17ab0a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 9, 2020
Manufacturers
FDA
Helsinn Therapeutics (U.S.), Inc.
DUNS: 829472583
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 Code69639-104
Application NumberNDA022233
Product Classification
M
Marketing Category
C73594
G
Generic Name
palonosetron hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2020
FDA Product Classification
INGREDIENTS (6)
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDESInactive
Code: U72Q2I8C85
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PALONOSETRON HYDROCHLORIDEActive
Quantity: 0.5 mg in 0.5 mg
Code: 23310D4I19
Classification: ACTIM
POLYGLYCERYL-10 OLEATEInactive
Code: 55C81W76DH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT