FDA.reportPublic FDA data

Application 077995

Type
ANDA
Sponsor
KUDCO IRELAND

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BICALUTAMIDEBICALUTAMIDETABLET;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077995-001BICALUTAMIDEBICALUTAMIDE50MGTABLET / ORAL2009-07-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06a50c72e98297…

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 · 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
brand name: Bicalutamide
generic name: BICALUTAMIDE
CASODEXBICALUTAMIDEANI Pharmaceuticals, Inc.dfee4fe7-8478-4a3e-925d-00be3cd0ab672026-02-27Warnings, Adverse reactionsName fallback
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEANI Pharmaceuticals, Inc.7a08d88b-051a-4c16-9560-12685c500c582026-02-27Warnings, Adverse reactionsName fallback
brand name: Bicalutamide
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEPINNACLE LIFE SCIENCE PRIVATE LIMITED8e7747d8-0e4f-4284-9cd1-407d0fe5b9462025-08-19Warnings, Adverse reactionsName fallback
brand name: Bicalutamide
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEViona Pharmaceuticals Inc.5a7cbe80-f119-4b3d-949a-c7824ea919082025-08-19Warnings, Adverse reactionsName fallback
brand name: Bicalutamide
generic name: BICALUTAMIDE
bicalutamideBICALUTAMIDESun Pharmaceutical Industries, Inc.8b533fe4-287f-482c-b530-d9a5bf2ce40c2025-01-28Warnings, Adverse reactionsName fallback
brand name: bicalutamide
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEBryant Ranch Prepack6d27f9b0-6b93-42fa-807e-fc819c0da14f2024-04-03Warnings, Adverse reactionsName fallback
brand name: Bicalutamide
generic name: BICALUTAMIDE
bicalutamideBICALUTAMIDEProficient Rx LP10e21544-f181-4cf8-9824-df0f49d195112024-03-01Warnings, Adverse reactionsName fallback
brand name: bicalutamide
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEAccord Healthcare Inc.7c295b64-ec39-42ec-9f02-da5b42e775e12024-01-16Warnings, Adverse reactionsName fallback
brand name: Bicalutamide
generic name: BICALUTAMIDE
BicalutamideBICALUTAMIDEProficient Rx LPc5c04006-0078-4fd7-9ecd-c50d8d9fa5d62022-11-01Warnings, Adverse reactionsName fallback
brand name: Bicalutamide
generic name: BICALUTAMIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-437Amlodipine BesylateAmlodipine BesylateAidarex Pharmaceuticals LLCANDACurrent
33261-535Amlodipine BesylateAmlodipine BesylateAidarex Pharmaceuticals LLCANDACurrent
33261-826Amlodipine BesylateAmlodipine BesylateAidarex Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39546ORIG2009-07-23
9106ORIG2009-07-09