Home Applications 207124 Application 207124
Type ANDA
Sponsor TEVA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG No No 002 DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG No No 003 DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207124-001 DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL AB 2022-09-23 A207124-002 DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL AB 2022-09-23 A207124-003 DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL AB 2022-09-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 of 3 · 87 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 2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207124-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL AB 2022-09-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207124-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL AB 2022-09-23 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A207124-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL AB 2022-09-23 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A207124-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL AB 2022-09-23 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207124-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL AB 2022-09-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207124-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL AB 2022-09-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207124-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL AB 2022-09-23 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
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 Deferasirox DEFERASIROX Teva Pharmaceuticals, Inc. e9054806-2721-4736-9aef-81ffb8db75d1 2024-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207124 application number: ANDA207124
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.