Proleukin
PROLEUKIN®
Approved
Approval ID
4e2b687e-47f2-4f3c-80ab-e3224befffca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2019
Manufacturers
FDA
Prometheus Laboratories Inc.
DUNS: 967000860
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 Code65483-116
Application NumberBLA103293
Product Classification
M
Marketing Category
C73585
G
Generic Name
aldesleukin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2018
FDA Product Classification
INGREDIENTS (6)
aldesleukinActive
Quantity: 1.1 mg in 1 mL
Code: M89N0Q7EQR
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT