FDA.reportPublic FDA data

Application 208539

Type
ANDA
Sponsor
MICRO LABS LTD

Application Products#

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

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

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
A208539-001TICAGRELORTICAGRELOR60MGTABLET / ORALAB2026-04-27
A208539-002TICAGRELORTICAGRELOR90MGTABLET / ORALAB2026-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208539-001AB
A208539-002AB

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
2026-09-14 22:38:342026-08A208539-001TICAGRELOR60MGTABLET / ORALAB2026-04-2784e616aacf4f…
2026-09-14 22:38:342026-08A208539-002TICAGRELOR90MGTABLET / ORALAB2026-04-2784e616aacf4f…
2026-08-18 06:07:402026-07A208539-001TICAGRELOR60MGTABLET / ORALAB2026-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07A208539-002TICAGRELOR90MGTABLET / ORALAB2026-04-27caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208539-001TICAGRELOR60MGTABLET / ORALAB2026-04-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208539-002TICAGRELOR90MGTABLET / ORALAB2026-04-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208539-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208539-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A208539-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208539-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208539-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208539-002AB1a50c72e98297…

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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
TicagrelorTICAGRELORAscend Laboratories, LLC3225098b-3138-4aec-a866-de94c3006e8e2025-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TICAGRELORTICAGRELORAvPAK425024ab-e092-7a6d-e063-6294a90ae4f32025-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TICAGRELOR
generic name: TICAGRELOR
TicagrelorTICAGRELORChangzhou Pharmaceutical Factory751410c1-452b-400b-a640-d31623a6fda32025-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORBIONPHARMA INC.4239fc4c-dae6-eb51-e063-6394a90a00d52025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELOROryza Pharmaceuticals, Inc.461d810e-5b77-5e53-e063-6294a90a64b02025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TICAGRELORTICAGRELORAvKARE40bb0fb0-2275-4df7-e063-6394a90ade2e2025-10-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TICAGRELOR
generic name: TICAGRELOR
TICAGRELORTICAGRELORAvKARE32ebf046-73e4-b11b-e063-6294a90a5bf42025-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TICAGRELOR
generic name: TICAGRELOR
TicagrelorTICAGRELOROryza Pharmaceuticals, Inc.32c950bd-7f5f-a811-e063-6394a90a00802025-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TicagrelorTICAGRELORMylan Pharmaceuticals Inc.fc333c4a-ad63-4d67-a3f7-431ac469d1162025-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
TICAGRELORTICAGRELORExelan Pharmaceuticals, Inceb8fb960-1f0e-40b1-9889-b02296bb3c372025-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TICAGRELOR
generic name: TICAGRELOR
TicagrelorTICAGRELORCipla USA Inc.789606e3-9efa-440c-84f1-f1c56fcbf0cd2025-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ticagrelor
generic name: TICAGRELOR
BRILINTATICAGRELORAphena Pharma Solutions - Tennessee, LLC1547e2b6-8858-178e-e063-6394a90abb232024-04-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TICAGRELOR

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55399ORIG2018-09-07