Bicalutamide
These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS.BICALUTAMIDE tablets, for oral useInitial U.S. Approval: 1995
Approved
Approval ID
7a08d88b-051a-4c16-9560-12685c500c58
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-890
Application NumberNDA020498
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bicalutamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2020
FDA Product Classification
INGREDIENTS (8)
BICALUTAMIDEActive
Quantity: 50 mg in 1 1
Code: A0Z3NAU9DP
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT