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 use Initial U.S. Approval: 1995
Approved
Approval ID
7c295b64-ec39-42ec-9f02-da5b42e775e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
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 Code16729-023
Application NumberANDA078917
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bicalutamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BICALUTAMIDEActive
Quantity: 50 mg in 1 1
Code: A0Z3NAU9DP
Classification: ACTIB