Home Applications 213374 Application 213374
Type ANDA
Sponsor ALKEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEFERASIROX DEFERASIROX GRANULE;ORAL 90MG No No 002 DEFERASIROX DEFERASIROX GRANULE;ORAL 180MG No No 003 DEFERASIROX DEFERASIROX GRANULE;ORAL 360MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A213374-001 DEFERASIROX DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 A213374-002 DEFERASIROX DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 A213374-003 DEFERASIROX DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14
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 1 of 3 · 111 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 2026-02-19 14:30 UTC 2026-02 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213374-002 DEFERASIROX 180MG GRANULE / ORAL AB 2020-07-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213374-003 DEFERASIROX 360MG GRANULE / ORAL AB 2020-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213374-001 DEFERASIROX 90MG GRANULE / ORAL AB 2020-07-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67877-675 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-675 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-675 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-675 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-676 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-676 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-676 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-676 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-677 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-677 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-677 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current 67877-677 Deferasirox oral Deferasirox oral Ascend Laboratories, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 64395 ORIG 2020-08-24