posfrea
These highlights do not include all the information needed to use POSFREA safely and effectively. See full prescribing information for POSFREA. POSFREA (palonosetron) injection, for intravenous use Initial U.S. Approval: 2003
Approved
Approval ID
13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 29, 2025
Manufacturers
FDA
Avyxa Pharma, LLC
DUNS: 128918748
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
palonosetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83831-104
Application NumberNDA203050
Product Classification
M
Marketing Category
C73594
G
Generic Name
palonosetron
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 29, 2025
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PALONOSETRON HYDROCHLORIDEActive
Quantity: 0.075 mg in 1.5 mL
Code: 23310D4I19
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
palonosetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83831-105
Application NumberNDA203050
Product Classification
M
Marketing Category
C73594
G
Generic Name
palonosetron
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 29, 2025
FDA Product Classification
INGREDIENTS (4)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
PALONOSETRON HYDROCHLORIDEActive
Quantity: 0.25 mg in 5 mL
Code: 23310D4I19
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT