Home Applications 203180 Application 203180
Type ANDA
Sponsor APOTEX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DASATINIB DASATINIB TABLET;ORAL 80MG No No 002 DASATINIB DASATINIB TABLET;ORAL 140MG 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 A203180-001 DASATINIB DASATINIB 80MG TABLET / ORAL AB 2021-11-23 A203180-002 DASATINIB DASATINIB 140MG TABLET / ORAL AB 2021-11-23
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 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203180-001 DASATINIB 80MG TABLET / ORAL 2021-11-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203180-002 DASATINIB 140MG TABLET / ORAL 2021-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203180-001 DASATINIB 80MG TABLET / ORAL 2021-11-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203180-002 DASATINIB 140MG TABLET / ORAL 2021-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203180-001 DASATINIB 80MG TABLET / ORAL 2021-11-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203180-002 DASATINIB 140MG TABLET / ORAL 2021-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203180-001 DASATINIB 80MG TABLET / ORAL 2021-11-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203180-002 DASATINIB 140MG TABLET / ORAL 2021-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203180-001 DASATINIB 80MG TABLET / ORAL 2021-11-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203180-002 DASATINIB 140MG TABLET / ORAL 2021-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203180-001 DASATINIB 80MG TABLET / ORAL AB 2021-11-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203180-002 DASATINIB 140MG TABLET / ORAL AB 2021-11-23 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity 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.
Documents# Document, Submission type, Date table Document Submission type Date 69683 ORIG 2021-12-20