FDA.reportPublic FDA data

Application 020863

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLETALCILOSTAZOLTABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002PLETALCILOSTAZOLTABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020863-001PLETALCILOSTAZOL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-15
N020863-002PLETALCILOSTAZOL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-15

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020863-001PLETAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-15a50c72e98297…
2026-08-01 22:54:322026-06N020863-002PLETAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-15a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cilostazolCILOSTAZOLAvKAREdc7c2c25-36a1-e3fd-e053-2995a90adabc2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL
cilostazolCILOSTAZOLAvPAKaec462c8-e225-f520-cae5-80049151c0ff2026-01-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL
CilostazolCILOSTAZOLSlate Run Pharmaceuticals, LLCdb0278e9-4ece-4aaf-9216-6bcbec58206a2025-12-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL
cilostazolCILOSTAZOLApotex Corp.ceac1ae3-c343-28ca-c083-b748d21a15e62025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL
CilostazolCILOSTAZOLChartwell RX, LLC77e77eaf-5556-43ac-844e-c0e29f02fe072025-09-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL
CILOSTAZOLCILOSTAZOLdirect rxb57d3c1e-e36f-5255-e053-2a95a90ada832025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL
CilostazolCILOSTAZOLBryant Ranch Prepackf728395c-684c-4087-a389-c323dbcb72dd2024-08-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL
cilostazolCILOSTAZOLAphena Pharma Solutions - Tennessee, LLC15ead884-bd4f-7f4b-e063-6394a90a8f812024-04-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL
cilostazolCILOSTAZOLAphena Pharma Solutions - Tennessee, LLC15478d90-312f-014e-e063-6294a90ae8382024-04-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL
CilostazolCILOSTAZOLBryant Ranch Prepack53486382-eee0-4cbe-bc4a-a57484e0d5a72024-01-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL
CilostazolCILOSTAZOLTeva Pharmaceuticals USA, Inc.a6292311-9cb2-49ff-b8bf-12e2dbd196cd2022-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CILOSTAZOL

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48454SUPPL2017-05-19
48449SUPPL2017-05-18
13637SUPPL2015-08-04
26076SUPPL2015-07-31
13636SUPPL2015-01-29
26075SUPPL2015-01-26
13635SUPPL2007-11-19
3601SUPPL2007-11-19
26074SUPPL2007-01-25
13634SUPPL2007-01-24
35526SUPPL2005-11-30
26073SUPPL2005-11-30
13633ORIG2004-06-14
3600SUPPL2004-03-03
21027ORIG1999-01-15
3599ORIG1999-01-15