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
c267f783-1d39-4f27-83ed-8288577bf66d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2010
Manufacturers
FDA
Synthon Pharmaceuticals, Inc.
DUNS: 013502302
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 Code63672-0005
Application NumberANDA077973
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bicalutamide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2010
FDA Product Classification
INGREDIENTS (9)
BicalutamideActive
Quantity: 50 mg in 1 1
Code: A0Z3NAU9DP
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT