FDA.reportPublic FDA data

Application 201503

Type
ANDA
Sponsor
APOTEX CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CABERGOLINECABERGOLINETABLET;ORAL0.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A201503-001CABERGOLINECABERGOLINE0.5MGTABLET / ORAL2013-03-08

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A201503-001CABERGOLINE0.5MGTABLET / ORAL2013-03-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201503-001CABERGOLINE0.5MGTABLET / ORAL2013-03-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201503-001CABERGOLINE0.5MGTABLET / ORAL2013-03-08a50c72e98297…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CabergolineCABERGOLINEMylan Pharmaceuticals Inc.e497366b-a124-4d7f-bd45-a883c392d4bb2026-06-30Warnings, Adverse reactionsName fallback
brand name: Cabergoline
generic name: CABERGOLINE
CABERGOLINECABERGOLINECranbury Pharmaceuticals, LLC8562f94f-a59a-4893-aefc-ea6547b01e922026-06-22Warnings, Adverse reactionsName fallback
brand name: CABERGOLINE
generic name: CABERGOLINE
CabergolineCABERGOLINEA-S Medication Solutionsc9f0b576-d5e5-4e3e-bb5c-3574d75d99072026-03-19Warnings, Adverse reactionsName fallback
brand name: Cabergoline
generic name: CABERGOLINE
CabergolineCABERGOLINESOLA Pharmaceuticals, LLC275a6a25-c3c9-4258-a610-0b00752517f72025-12-08Warnings, Adverse reactionsName fallback
brand name: Cabergoline
generic name: CABERGOLINE
CabergolineCABERGOLINEA-S Medication Solutions9405c116-4a77-4e14-9ab8-25e899595cdf2025-08-27Warnings, Adverse reactionsName fallback
brand name: Cabergoline
generic name: CABERGOLINE
CabergolineCABERGOLINEIngenus Pharmaceuticals, LLC57cbd81e-fdb9-4060-80ee-6e8581c463a42025-07-04Warnings, Adverse reactionsName fallback
brand name: Cabergoline
generic name: CABERGOLINE
CabergolineCABERGOLINETeva Pharmaceuticals USA, Inc.74b61e8a-7ae9-4996-85ec-df23c56de16f2025-06-16Warnings, Adverse reactionsName fallback
brand name: Cabergoline
generic name: CABERGOLINE
CABERGOLINECABERGOLINESomerset Therapeutics, LLCe0fb5556-de2c-4822-9960-0700e29078902024-11-14Warnings, Adverse reactionsName fallback
brand name: CABERGOLINE
generic name: CABERGOLINE
CabergolineCABERGOLINEAmneal Pharmaceuticals NY LLCa246b015-e19c-4b4f-9089-aea1108687ba2024-10-03Warnings, Adverse reactionsName fallback
brand name: Cabergoline
generic name: CABERGOLINE
CabergolineCABERGOLINEA-S Medication Solutions7699d938-3f62-4e13-9b33-3e581310b9f32023-08-28Warnings, Adverse reactionsName fallback
brand name: Cabergoline
generic name: CABERGOLINE
CabergolineCABERGOLINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.bc44d11b-b3f0-4e3d-9da3-4f8852d117342023-07-27Warnings, Adverse reactionsName fallback
brand name: Cabergoline
generic name: CABERGOLINE
CabergolineCABERGOLINEA-S Medication Solutions89ec147b-a6fe-49bb-9af5-52fc2ce5db7f2023-04-12Warnings, Adverse reactionsName fallback
brand name: Cabergoline
generic name: CABERGOLINE

Reported adverse events (FAERS/openFDA)#

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