Home Applications 208390 Application 208390
Type ANDA
Sponsor WATSON LABS INC 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 43 .
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 A208390-001 TICAGRELOR TICAGRELOR 60MG TABLET / ORAL AB 2018-09-04 A208390-002 TICAGRELOR TICAGRELOR 90MG TABLET / ORAL AB 2018-09-04
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A208390-001 TICAGRELOR 60MG TABLET / ORAL AB 2018-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208390-002 TICAGRELOR 90MG TABLET / ORAL AB 2018-09-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208390-001 TICAGRELOR 60MG TABLET / ORAL AB 2018-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208390-002 TICAGRELOR 90MG TABLET / ORAL AB 2018-09-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208390-001 TICAGRELOR 60MG TABLET / ORAL AB 2018-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208390-002 TICAGRELOR 90MG TABLET / ORAL AB 2018-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208390-001 TICAGRELOR 60MG TABLET / ORAL AB 2018-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208390-002 TICAGRELOR 90MG TABLET / ORAL AB 2018-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208390-001 TICAGRELOR 60MG TABLET / ORAL AB 2018-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208390-002 TICAGRELOR 90MG TABLET / ORAL AB 2018-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208390-001 TICAGRELOR 60MG TABLET / ORAL 2018-09-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208390-002 TICAGRELOR 90MG TABLET / ORAL 2018-09-04 74a2ff9319b5…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208390-001 PC 2025-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208390-001 PC 2025-10-28 6a471c1ec25d…
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 Teva Pharmaceuticals, Inc. 1bbdc202-bbe4-4aec-b4e9-1f1feb41d819 2026-08-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208390 application number: ANDA208390
Documents# Document, Submission type, Date table Document Submission type Date 53804 ORIG 2018-04-24