Home Applications 208597 Application 208597
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TICAGRELOR TICAGRELOR TABLET;ORAL 60MG No No 002 TICAGRELOR TICAGRELOR TABLET;ORAL 90MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208597-001 TICAGRELOR TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 A208597-002 TICAGRELOR TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 1 of 2 · 68 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 782e0a99824c…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ticagrelor TICAGRELOR Mylan Pharmaceuticals Inc. fc333c4a-ad63-4d67-a3f7-431ac469d116 2025-04-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208597 application number: ANDA208597