Home Applications 205874 Application 205874
Type NDA
Sponsor KERYX BIOPHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AURYXIA FERRIC CITRATE TABLET;ORAL EQ 210MG IRON Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N205874-001 AURYXIA FERRIC CITRATE EQ 210MG IRON TABLET / ORAL AB RLD, RS 2014-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N205874-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205874-001 8093423 2026-04-21 U-1577 2014-10-02 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 N205874-001 9387191 2030-07-21 Drug product 2016-08-09
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 2 · 41 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 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205874-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 14 · 526 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 7767851 2024-02-18 Drug substance, Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8299298 2024-02-18 Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8338642 2024-02-18 U-1577 Drug substance, Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8609896 2024-02-18 Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8754257 2024-02-18 Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8754258 2024-02-18 Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8846976 2024-02-18 U-1577 2014-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8901349 2024-02-18 U-1577 2015-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 9050316 2024-02-18 U-1577 2015-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 9328133 2024-02-18 U-1577 Drug substance, Drug product 2016-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 9757416 2024-02-18 U-1577 Drug substance, Drug product 2017-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 7767851 2024-02-18 Drug substance, Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8299298 2024-02-18 Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8338642 2024-02-18 U-1577 Drug substance, Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8609896 2024-02-18 Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8754257 2024-02-18 Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8754258 2024-02-18 Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8846976 2024-02-18 U-1577 2014-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8901349 2024-02-18 U-1577 2015-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 9050316 2024-02-18 U-1577 2015-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 9328133 2024-02-18 U-1577 Drug substance, Drug product 2016-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 9757416 2024-02-18 U-1577 Drug substance, Drug product 2017-10-05 2680178bc6a6…
Observed Orange Book exclusivity history# 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59922-631 Auryxia ferric citrate Akebia Therapeutics, Inc. NDA Current 59922-631 Auryxia ferric citrate Akebia Therapeutics, Inc. NDA Current 59922-631 Auryxia ferric citrate Akebia Therapeutics, Inc. NDA Current 59922-631 Auryxia ferric citrate Keryx Biopharmaceuticals, Inc. NDA Current 59922-631 Auryxia ferric citrate Keryx Biopharmaceuticals, Inc. NDA Current 59922-631 Auryxia ferric citrate Keryx Biopharmaceuticals, Inc. NDA Current 59922-631 Auryxia ferric citrate Keryx Biopharmaceuticals, Inc. NDA Current