FDA.reportPublic FDA data

Application 208531

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

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

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

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
A208531-001TICAGRELORTICAGRELOR90MGTABLET / ORAL2019-01-23
A208531-002TICAGRELORTICAGRELOR60MGTABLET / ORAL2025-10-28

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 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208531-001TICAGRELOR90MGTABLET / ORAL2019-01-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208531-001TICAGRELOR90MGTABLET / ORAL2019-01-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A208531-001TICAGRELOR90MGTABLET / ORAL2019-01-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A208531-001TICAGRELOR90MGTABLET / ORAL2019-01-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208531-001TICAGRELOR90MGTABLET / ORAL2019-01-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208531-001TICAGRELOR90MGTABLET / ORAL2019-01-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208531-001TICAGRELOR90MGTABLET / ORAL2019-01-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208531-001TICAGRELOR90MGTABLET / ORAL2019-01-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208531-001TICAGRELOR90MGTABLET / ORAL2019-01-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208531-002TICAGRELOR60MGTABLET / ORAL2025-10-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208531-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208531-002AB131067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208531-001PC2025-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208531-001PC2025-10-286a471c1ec25d…

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-e063-6394a90afb512026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
ticagrelorTICAGRELORScieGen Pharmaceuticals INC40ac26dc-2570-de7e-e063-6294a90ade722026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORTeva Pharmaceuticals, Inc.1bbdc202-bbe4-4aec-b4e9-1f1feb41d8192026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORLaurus Labs Limited555d4e44-9bb2-474e-9bea-c549e3261dbb2026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TICAGRELORTICAGRELORAphena Pharma Solutions - Tennessee, LLC5955a5f5-fbc7-8f67-e063-6394a90ada362026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TICAGRELOR
generic name: TICAGRELOR
TicagrelorTICAGRELORHisun Pharmaceuticals USA, Inc.c4c1ca82-99bd-451a-ad77-7fe28c4ae3e82026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORAiPing Pharmaceutical, Inc4ecb82df-fad2-1f6c-e063-6294a90a9d192026-07-16Boxed 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
TicagrelorTICAGRELORNorthStar RxLLCc89c29c9-d2c0-4605-b74f-059e0b1049772026-06-10Boxed 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
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
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
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

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1134ticagrelorticagrelorAmneal Pharmaceuticals NY LLCANDACurrent
69238-1134ticagrelorticagrelorAmneal Pharmaceuticals NY LLCANDACurrent
69238-1134ticagrelorticagrelorAmneal Pharmaceuticals NY LLCANDACurrent
69238-1134TicagrelorTicagrelorAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57716ORIG2019-02-21