Home Applications 202103 Application 202103
Type ANDA
Sponsor APOTEX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DASATINIB DASATINIB TABLET;ORAL 20MG No No 002 DASATINIB DASATINIB TABLET;ORAL 50MG No No 003 DASATINIB DASATINIB TABLET;ORAL 70MG No No 004 DASATINIB DASATINIB TABLET;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202103-001 DASATINIB DASATINIB 20MG TABLET / ORAL AB 2016-06-10 A202103-002 DASATINIB DASATINIB 50MG TABLET / ORAL AB 2016-06-10 A202103-003 DASATINIB DASATINIB 70MG TABLET / ORAL AB 2016-06-10 A202103-004 DASATINIB DASATINIB 100MG TABLET / ORAL AB 2016-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 168 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 A202103-001 DASATINIB 20MG TABLET / ORAL AB 2016-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202103-002 DASATINIB 50MG TABLET / ORAL AB 2016-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202103-003 DASATINIB 70MG TABLET / ORAL AB 2016-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202103-004 DASATINIB 100MG TABLET / ORAL AB 2016-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202103-001 DASATINIB 20MG TABLET / ORAL AB 2016-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202103-002 DASATINIB 50MG TABLET / ORAL AB 2016-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202103-003 DASATINIB 70MG TABLET / ORAL AB 2016-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202103-004 DASATINIB 100MG TABLET / ORAL AB 2016-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202103-001 DASATINIB 20MG TABLET / ORAL AB 2016-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202103-002 DASATINIB 50MG TABLET / ORAL AB 2016-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202103-003 DASATINIB 70MG TABLET / ORAL AB 2016-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202103-004 DASATINIB 100MG TABLET / ORAL AB 2016-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202103-001 DASATINIB 20MG TABLET / ORAL AB 2016-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202103-002 DASATINIB 50MG TABLET / ORAL AB 2016-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202103-003 DASATINIB 70MG TABLET / ORAL AB 2016-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202103-004 DASATINIB 100MG TABLET / ORAL AB 2016-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202103-001 DASATINIB 20MG TABLET / ORAL AB 2016-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202103-002 DASATINIB 50MG TABLET / ORAL AB 2016-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202103-003 DASATINIB 70MG TABLET / ORAL AB 2016-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202103-004 DASATINIB 100MG TABLET / ORAL AB 2016-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202103-001 DASATINIB 20MG TABLET / ORAL AB 2016-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202103-002 DASATINIB 50MG TABLET / ORAL AB 2016-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202103-003 DASATINIB 70MG TABLET / ORAL AB 2016-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202103-004 DASATINIB 100MG TABLET / ORAL AB 2016-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202103-001 DASATINIB 20MG TABLET / ORAL AB 2016-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202103-002 DASATINIB 50MG TABLET / ORAL AB 2016-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202103-003 DASATINIB 70MG TABLET / ORAL AB 2016-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202103-004 DASATINIB 100MG TABLET / ORAL AB 2016-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202103-001 DASATINIB 20MG TABLET / ORAL AB 2016-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202103-002 DASATINIB 50MG TABLET / ORAL AB 2016-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202103-003 DASATINIB 70MG TABLET / ORAL AB 2016-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202103-004 DASATINIB 100MG TABLET / ORAL AB 2016-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202103-001 DASATINIB 20MG TABLET / ORAL AB 2016-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202103-002 DASATINIB 50MG TABLET / ORAL AB 2016-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202103-003 DASATINIB 70MG TABLET / ORAL AB 2016-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202103-004 DASATINIB 100MG TABLET / ORAL AB 2016-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202103-001 DASATINIB 20MG TABLET / ORAL AB 2016-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202103-002 DASATINIB 50MG TABLET / ORAL AB 2016-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202103-003 DASATINIB 70MG TABLET / ORAL AB 2016-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202103-004 DASATINIB 100MG TABLET / ORAL AB 2016-06-10 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
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 62200 ORIG 2020-03-19 32180 ORIG 2016-06-14