bicalutamide
These highlights do not include all the information needed to use Bicalutamide Tablets safely and effectively. See full prescribing information for Bicalutamide Tablets. Initial U.S. Approval: 1995
Approved
Approval ID
c6e9ca46-4552-4978-9d24-83ef7cadeebe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2010
Manufacturers
FDA
Kremers Urban
DUNS: 015411751
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 Code62175-132
Application NumberANDA077995
Product Classification
M
Marketing Category
C73584
G
Generic Name
bicalutamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2009
FDA Product Classification
INGREDIENTS (1)
BICALUTAMIDEActive
Quantity: 50 mg in 1 1
Code: A0Z3NAU9DP
Classification: ACTIB