Home Applications 021825 Application 021825
Type NDA
Sponsor CHIESI Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FERRIPROX DEFERIPRONE TABLET;ORAL 500MG Yes Yes 002 FERRIPROX DEFERIPRONE TABLET;ORAL 1GM Yes 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 N021825-001 FERRIPROX DEFERIPRONE 500MG TABLET / ORAL RLD 2011-10-14 N021825-002 FERRIPROX DEFERIPRONE 1GM TABLET / ORAL AB RLD 2019-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021825-002 AB
Orange Book exclusivity# Current exclusivity 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.
Product history page 1 of 3 · 83 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 N021825-001 FERRIPROX 500MG TABLET / ORAL RLD 2011-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD, RS 2011-10-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD, RS 2011-10-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD, RS 2011-10-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021825-001 FERRIPROX 500MG TABLET / ORAL RLD, RS 2011-10-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021825-002 FERRIPROX 1GM TABLET / ORAL RLD 2019-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD, RS 2011-10-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021825-001 7049328 2021-06-28 U-735 2015-10-08 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021825-001 7049328 2021-06-28 U-3083 2015-10-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021825-002 7049328 2021-06-28 U-3083 2020-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021825-001 7049328 2021-06-28 U-735 2015-10-08 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021825-002 7049328 2021-06-28 U-735 2020-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021825-001 7049328 2021-06-28 U-735 2015-10-08 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021825-002 7049328 2021-06-28 U-735 2020-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021825-001 7049328 2021-06-28 U-735 2015-10-08 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021825-002 7049328 2021-06-28 U-735 2020-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021825-001 7049328 2021-06-28 U-735 2015-10-08 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021825-002 7049328 2021-06-28 U-735 2020-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021825-001 7049328 2021-06-28 U-735 2015-10-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021825-001 7049328 2021-06-28 U-735 2015-10-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021825-001 7049328 2021-06-28 U-735 2015-10-08 ea99ee380514…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 198 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10122-100 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 10122-100 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 10122-100 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 10122-100 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 10122-103 FERRIPROX DEFERIPRONE Chiesi USA, Inc. NDA Current 10122-103 FERRIPROX DEFERIPRONE Chiesi USA, Inc. NDA Current 10122-103 FERRIPROX DEFERIPRONE Chiesi USA, Inc. NDA Current 10122-103 FERRIPROX DEFERIPRONE Chiesi USA, Inc. NDA Current 52609-0006 FERRIPROX deferiprone ApoPharma USA, Inc. NDA Current 52609-0006 FERRIPROX deferiprone ApoPharma USA, Inc. NDA Current 52609-0006 FERRIPROX deferiprone ApoPharma USA, Inc. NDA Current 52609-0007 FERRIPROX deferiprone ApoPharma USA, Inc. NDA Current 52609-0007 FERRIPROX deferiprone ApoPharma USA, Inc. NDA Current 52609-0007 FERRIPROX deferiprone ApoPharma USA, Inc. NDA Current