Bicalutamide
These highlights do not include all the information needed to use bicalutamide tablets USP safely and effectively. See full prescribing information for bicalutamide tablets USP. Bicalutamide Tablets USP for Oral useInitial U.S. Approval: 1995
Approved
Approval ID
020d34eb-9560-4218-9d87-dfdeff705c3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6133
Application NumberANDA076932
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 11, 2010
Generic NameBicalutamide
INGREDIENTS (12)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
BICALUTAMIDEActive
Quantity: 50 mg in 1 1
Code: A0Z3NAU9DP
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT