Home Applications 208030 Application 208030
Type NDA
Sponsor CHIESI Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FERRIPROX DEFERIPRONE SOLUTION;ORAL 100MG/ML Yes Yes 002 FERRIPROX DEFERIPRONE SOLUTION;ORAL 80MG/ML 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 N208030-001 FERRIPROX DEFERIPRONE 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 N208030-002 FERRIPROX DEFERIPRONE 80MG/ML SOLUTION / ORAL RLD 2018-04-20
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31
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 · 84 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 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 3 · 102 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 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208030-001 7049328 2021-06-28 U-735 2015-10-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208030-001 8703156 2029-10-29 U-735 Drug product 2015-10-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208030-002 7049328 2021-06-28 U-735 2019-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208030-002 8703156 2029-10-29 U-735 Drug product 2019-01-31 74a2ff9319b5…
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10122-101 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 10122-101 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 10122-101 FERRIPROX deferiprone Chiesi USA, Inc. NDA Current 52609-4502 FERRIPROX deferiprone ApoPharma USA, Inc. NDA Current 52609-4502 FERRIPROX deferiprone ApoPharma USA, Inc. NDA Current 52609-4502 FERRIPROX deferiprone ApoPharma USA, Inc. NDA Current