Proleukin
These highlights do not include all the information needed to use PROLEUKIN® safely and effectively. See full prescribing information for PROLEUKIN. PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992
Approved
Approval ID
deead498-9f19-48cf-87c7-6caf2263f2ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2023
Manufacturers
FDA
Clinigen Limited
DUNS: 211471076
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
aldesleukin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76310-022
Application NumberBLA103293
Product Classification
M
Marketing Category
C73585
G
Generic Name
aldesleukin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 19, 2019
FDA Product Classification
INGREDIENTS (6)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
aldesleukinActive
Quantity: 1.1 mg in 1 mL
Code: M89N0Q7EQR
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT