Home Applications 212269 Application 212269
Type NDA
Sponsor APOPHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FERRIPROX DEFERIPRONE TABLET;ORAL 1000MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212269-001 FERRIPROX DEFERIPRONE 1GM TABLET / ORAL RLD, RS 2020-05-19
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 N212269-001 11723874 2038-10-25 U-3083 2023-09-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212269-001 ODE-417 2028-04-30 N212269-001 ODE-420 2028-04-30 N212269-001 ODE-421 2028-04-30
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 2026-08-18 06:07:40 2026-07 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 189 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 99 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10122-104 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 10122-104 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 10122-104 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 10122-104 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 10122-104 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current