FDA.reportPublic FDA data

Application 077028

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CILOSTAZOLCILOSTAZOLTABLET; ORAL100MGNoNo
002CILOSTAZOLCILOSTAZOLTABLET;ORAL100MGNoNo

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
A077028-002CILOSTAZOLCILOSTAZOL100MGTABLET / ORAL2004-11-26

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 UTC2022-10A077028-002CILOSTAZOL100MGTABLET / ORAL2004-11-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077028-002CILOSTAZOL100MGTABLET / ORAL2004-11-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077028-002CILOSTAZOL100MGTABLET / ORAL2004-11-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077028-002CILOSTAZOL100MGTABLET / ORAL2004-11-26a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cilostazolCILOSTAZOLApotex Corp.ceac1ae3-c343-28ca-c083-b748d21a15e62026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: cilostazol
generic name: CILOSTAZOL
cilostazolCILOSTAZOLAvKAREdc7c2c25-36a1-e3fd-e053-2995a90adabc2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: cilostazol
generic name: CILOSTAZOL
cilostazolCILOSTAZOLAvPAKaec462c8-e225-f520-cae5-80049151c0ff2026-01-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: cilostazol
generic name: CILOSTAZOL
CilostazolCILOSTAZOLSlate Run Pharmaceuticals, LLCdb0278e9-4ece-4aaf-9216-6bcbec58206a2025-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cilostazol
generic name: CILOSTAZOL
CilostazolCILOSTAZOLChartwell RX, LLC77e77eaf-5556-43ac-844e-c0e29f02fe072025-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cilostazol
generic name: CILOSTAZOL
CILOSTAZOLCILOSTAZOLdirect rxb57d3c1e-e36f-5255-e053-2a95a90ada832025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CILOSTAZOL
generic name: CILOSTAZOL
CilostazolCILOSTAZOLBryant Ranch Prepackf728395c-684c-4087-a389-c323dbcb72dd2024-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cilostazol
generic name: CILOSTAZOL
cilostazolCILOSTAZOLAphena Pharma Solutions - Tennessee, LLC15ead884-bd4f-7f4b-e063-6394a90a8f812024-04-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: cilostazol
generic name: CILOSTAZOL
cilostazolCILOSTAZOLAphena Pharma Solutions - Tennessee, LLC15478d90-312f-014e-e063-6294a90ae8382024-04-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: cilostazol
generic name: CILOSTAZOL
CilostazolCILOSTAZOLBryant Ranch Prepack53486382-eee0-4cbe-bc4a-a57484e0d5a72024-01-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cilostazol
generic name: CILOSTAZOL
CilostazolCILOSTAZOLTeva Pharmaceuticals USA, Inc.a6292311-9cb2-49ff-b8bf-12e2dbd196cd2022-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cilostazol
generic name: CILOSTAZOL

Reported adverse events (FAERS/openFDA)#

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