FDA.reportPublic FDA data

Application 022310

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CASODEXBICALUTAMIDETABLET; ORAL50MGYesNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BicalutamideBICALUTAMIDEGolden State Medical Supply, Inc.26e30155-a50b-df14-e063-6394a90a9be42026-04-23Warnings, Adverse reactionsName fallback
generic name: BICALUTAMIDE
CASODEXBICALUTAMIDEANI Pharmaceuticals, Inc.dfee4fe7-8478-4a3e-925d-00be3cd0ab672026-02-27Warnings, Adverse reactionsName fallback
brand name: CASODEX
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEANI Pharmaceuticals, Inc.7a08d88b-051a-4c16-9560-12685c500c582026-02-27Warnings, Adverse reactionsName fallback
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEPINNACLE LIFE SCIENCE PRIVATE LIMITED8e7747d8-0e4f-4284-9cd1-407d0fe5b9462025-08-19Warnings, Adverse reactionsName fallback
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEViona Pharmaceuticals Inc.5a7cbe80-f119-4b3d-949a-c7824ea919082025-08-19Warnings, Adverse reactionsName fallback
generic name: BICALUTAMIDE
bicalutamideBICALUTAMIDESun Pharmaceutical Industries, Inc.8b533fe4-287f-482c-b530-d9a5bf2ce40c2025-01-28Warnings, Adverse reactionsName fallback
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEBryant Ranch Prepack6d27f9b0-6b93-42fa-807e-fc819c0da14f2024-04-03Warnings, Adverse reactionsName fallback
generic name: BICALUTAMIDE
bicalutamideBICALUTAMIDEProficient Rx LP10e21544-f181-4cf8-9824-df0f49d195112024-03-01Warnings, Adverse reactionsName fallback
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEAccord Healthcare Inc.7c295b64-ec39-42ec-9f02-da5b42e775e12024-01-16Warnings, Adverse reactionsName fallback
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEProficient Rx LPc5c04006-0078-4fd7-9ecd-c50d8d9fa5d62022-11-01Warnings, Adverse reactionsName fallback
generic name: BICALUTAMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42487ORIG2009-09-30
17224ORIG2009-01-06
29572ORIG2008-12-29
53198ORIG1900-01-01
53197ORIG1900-01-01
53196ORIG1900-01-01