CASODEX
These highlights do not include all the information needed to use CASODEX safely and effectively. See full prescribing information for CASODEX.CASODEX (bicalutamide) tablet, for oral useInitial U.S. Approval: 1995
Approved
Approval ID
dfee4fe7-8478-4a3e-925d-00be3cd0ab67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bicalutamide
PRODUCT DETAILS
NDC Product Code62559-680
Application NumberNDA020498
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 30, 2019
Generic NameBicalutamide
INGREDIENTS (8)
BICALUTAMIDEActive
Quantity: 50 mg in 1 1
Code: A0Z3NAU9DP
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT