FDA.reportPublic FDA data

Application 211498

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TICAGRELORTICAGRELORTABLET;ORAL60MGNoNo
002TICAGRELORTICAGRELORTABLET;ORAL90MGNoNo

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
A211498-001TICAGRELORTICAGRELOR60MGTABLET / ORALAB2025-10-28
A211498-002TICAGRELORTICAGRELOR90MGTABLET / ORALAB2025-10-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A211498-001AB
A211498-002AB

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
2026-02-19 14:30 UTC2026-02A211498-001TICAGRELOR60MGTABLET / ORALAB2025-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211498-002TICAGRELOR90MGTABLET / ORALAB2025-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211498-001TICAGRELOR60MGTABLET / ORALAB2025-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211498-002TICAGRELOR90MGTABLET / ORALAB2025-10-2831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211498-001TICAGRELOR60MGTABLET / ORALAB2025-10-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211498-002TICAGRELOR90MGTABLET / ORALAB2025-10-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211498-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211498-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211498-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211498-002AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211498-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211498-002AB1a50c72e98297…

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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TicagrelorTICAGRELORRedpharm Drug557351f1-47b7-216d-e063-6394a90afb512026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORGolden State Medical Supply, Inc.37f1d3d7-030f-180a-e063-6294a90a89da2026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORMacleods Pharmaceuticals Limited32769721-c1dd-4bd3-90aa-a6cab59d3cd62026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORAiPing Pharmaceutical, Inc4ecb82df-fad2-1f6c-e063-6294a90a9d192026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORApotex Corp.2c59ea45-6113-6e9e-70b5-3b8c8b3d89b62026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORDr. Reddys Laboratories Inc1225fd45-9b56-1671-ee77-cd0c9f2174a52026-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORLifestar Pharma LLC7efe86fa-5d19-413a-8b15-e51279b62f3f2026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORAscend Laboratories, LLC2f73a4db-2c7f-4e42-a914-87aedc2780fb2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
BRILINTATICAGRELORAstraZeneca Pharmaceuticals LPf7b3f443-e83d-4bf2-0e96-023448fed9a82026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TICAGRELOR
BRILINTATICAGRELORCardinal Health 107, LLC4f9bd52a-99a7-4606-92b4-456a917aabef2026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TICAGRELOR
TicagrelorTICAGRELORHisun Pharmaceuticals USA, Inc.c4c1ca82-99bd-451a-ad77-7fe28c4ae3e82026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TICAGRELORTICAGRELORNovadoz Pharmaceuticals LLCb1c29d47-960f-4fc4-b6ff-399e2c6eec4c2026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TICAGRELOR
generic name: TICAGRELOR
TICAGRELORTICAGRELORAphena Pharma Solutions - Tennessee, LLC37b2d081-c17a-c126-e063-6394a90a57292026-01-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TICAGRELOR
generic name: TICAGRELOR
TicagrelorTICAGRELORAmerican Health Packaginga50eb0b4-1bee-4781-8eba-75e324540d362026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
ticagrelorTICAGRELORScieGen Pharmaceuticals INC40ac26dc-2570-de7e-e063-6294a90ade722025-12-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORAphena Pharma Solutions - Tennessee, LLC41c5d35c-91de-a8a4-e063-6394a90ac5ff2025-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
ticagrelorTICAGRELORRadha Pharmaceuticals INC436d1bef-da01-7d0a-e063-6294a90abd902025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ticagrelor
generic name: TICAGRELOR
TICAGRELORTICAGRELORSolco Healthcare U.S., LLC5be5ef20-fc9f-4c3b-a482-83ffd8a3ab472025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TICAGRELOR
generic name: TICAGRELOR
TicagrelorTICAGRELORAlembic Pharmaceuticals Inc.d68b79ab-3104-410e-a63f-9919a23625af2025-10-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORAlembic Pharmaceuticals Limited82f66384-e2c7-41c5-961f-384918ef58ec2025-10-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR