Home Applications 213383 Application 213383
Type ANDA
Sponsor DR REDDYS LABS LTD 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 80MG No No 005 DASATINIB DASATINIB TABLET;ORAL 100MG No No 006 DASATINIB DASATINIB TABLET;ORAL 140MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213383-001 DASATINIB DASATINIB 20MG TABLET / ORAL AB 2025-03-03 A213383-002 DASATINIB DASATINIB 50MG TABLET / ORAL AB 2025-03-03 A213383-003 DASATINIB DASATINIB 70MG TABLET / ORAL AB 2025-03-03 A213383-004 DASATINIB DASATINIB 80MG TABLET / ORAL AB 2025-03-03 A213383-005 DASATINIB DASATINIB 100MG TABLET / ORAL AB 2025-03-03 A213383-006 DASATINIB DASATINIB 140MG TABLET / ORAL AB 2025-03-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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.
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 2026-02-19 14:30 UTC 2026-02 A213383-001 DASATINIB 20MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213383-002 DASATINIB 50MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213383-003 DASATINIB 70MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213383-004 DASATINIB 80MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213383-005 DASATINIB 100MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213383-006 DASATINIB 140MG TABLET / ORAL AB 2025-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213383-001 DASATINIB 20MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213383-002 DASATINIB 50MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213383-003 DASATINIB 70MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213383-004 DASATINIB 80MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213383-005 DASATINIB 100MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213383-006 DASATINIB 140MG TABLET / ORAL AB 2025-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213383-001 DASATINIB 20MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213383-002 DASATINIB 50MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213383-003 DASATINIB 70MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213383-004 DASATINIB 80MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213383-005 DASATINIB 100MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213383-006 DASATINIB 140MG TABLET / ORAL AB 2025-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213383-001 DASATINIB 20MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213383-002 DASATINIB 50MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213383-003 DASATINIB 70MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213383-004 DASATINIB 80MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213383-005 DASATINIB 100MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213383-006 DASATINIB 140MG TABLET / ORAL AB 2025-03-03 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213383-001 DASATINIB 20MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213383-002 DASATINIB 50MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213383-003 DASATINIB 70MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213383-004 DASATINIB 80MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213383-005 DASATINIB 100MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213383-006 DASATINIB 140MG TABLET / ORAL AB 2025-03-03 a50c72e98297…
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 Dasatinib DASATINIB Dr.Reddys Laboratories Inc eb5ddff2-6521-b461-43ac-80ff8660b20b 2025-03-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 213383 application number: ANDA213383
Documents# Document, Submission type, Date table Document Submission type Date 69656 ORIG 2021-12-20