ALIQOPA
These highlights do not include all the information needed to use ALIQOPA safely and effectively. See full prescribing information for ALIQOPA. Initial U.S. Approval: 2017
Approved
Approval ID
ade50241-2c10-4038-b4e9-72f6bf905f03
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 7, 2023
Manufacturers
FDA
Bayer HealthCare Pharmaceuticals Inc.
DUNS: 005436809
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
copanlisib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-385
Application NumberNDA209936
Product Classification
M
Marketing Category
C73594
G
Generic Name
copanlisib
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2017
FDA Product Classification
INGREDIENTS (4)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
COPANLISIBActive
Quantity: 15 mg in 1 mL
Code: WI6V529FZ9
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT