Home Applications 205109 Application 205109
Type NDA
Sponsor VIFOR FRESENIUS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VELPHORO SUCROFERRIC OXYHYDROXIDE TABLET, CHEWABLE;ORAL 500MG 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 N205109-001 VELPHORO FERRIC OXYHYDROXIDE EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27
Orange Book patents# Current patent rows page 1 of 1 · 22 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205109-001 10682376 2028-11-13 Drug product 2020-06-17 N205109-001 10695367 2028-11-13 Drug product 2020-07-01 N205109-001 10925896 2028-11-13 Drug product 2021-03-10 N205109-001 10925897 2028-11-13 Drug product 2021-03-10 N205109-001 10933090 2028-11-13 Drug product 2021-03-10 N205109-001 11013761 2028-11-13 Drug product 2021-06-02 N205109-001 11013762 2028-11-13 Drug product 2021-06-02 N205109-001 10682376*PED 2029-05-13 Pediatric extension N205109-001 10695367*PED 2029-05-13 Pediatric extension N205109-001 10925896*PED 2029-05-13 Pediatric extension N205109-001 10925897*PED 2029-05-13 Pediatric extension N205109-001 10933090*PED 2029-05-13 Pediatric extension N205109-001 11013761*PED 2029-05-13 Pediatric extension N205109-001 11013762*PED 2029-05-13 Pediatric extension N205109-001 9561251 2030-01-23 U-1468 Drug product 2017-03-02 N205109-001 9561251*PED 2030-07-23 Pediatric extension N205109-001 10624855 2034-11-26 Drug product 2020-04-27 N205109-001 11234938 2034-11-26 Drug product 2022-02-17 N205109-001 11446252 2034-11-26 Drug product 2022-09-20 N205109-001 10624855*PED 2035-05-26 Pediatric extension N205109-001 11234938*PED 2035-05-26 Pediatric extension N205109-001 11446252*PED 2035-05-26 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N205109-001 NPP 2027-07-01 N205109-001 PED 2028-01-01
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 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205109-001 VELPHORO 500MG TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 19 · 728 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 N205109-001 10682376 2028-11-13 Drug product 2020-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10695367 2028-11-13 Drug product 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10925896 2028-11-13 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10925897 2028-11-13 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10933090 2028-11-13 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11013761 2028-11-13 Drug product 2021-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11013762 2028-11-13 Drug product 2021-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10682376*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10695367*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10925896*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10925897*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10933090*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11013761*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11013762*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 9561251 2030-01-23 U-1468 Drug product 2017-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 9561251*PED 2030-07-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10624855 2034-11-26 Drug product 2020-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11234938 2034-11-26 Drug product 2022-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11446252 2034-11-26 Drug product 2022-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 10624855*PED 2035-05-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11234938*PED 2035-05-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205109-001 11446252*PED 2035-05-26 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10682376 2028-11-13 Drug product 2020-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10695367 2028-11-13 Drug product 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10925896 2028-11-13 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10925897 2028-11-13 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10933090 2028-11-13 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 11013761 2028-11-13 Drug product 2021-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 11013762 2028-11-13 Drug product 2021-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10682376*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10695367*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10925896*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10925897*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10933090*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 11013761*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 11013762*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 9561251 2030-01-23 U-1468 Drug product 2017-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 9561251*PED 2030-07-23 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 10624855 2034-11-26 Drug product 2020-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205109-001 11234938 2034-11-26 Drug product 2022-02-17 31067a03dcf5…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Velphoro SUCROFERRIC OXYHYDROXIDE Fresenius Medical Care Renal Therapies Group, LLC 237da26c-f38c-4faa-93ad-735e71c9d0c1 2026-04-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 205109 application number: NDA205109 ndc (product): 49230-645
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49230-645 Velphoro sucroferric oxyhydroxide Fresenius Medical Care North America NDA Current 49230-645 Velphoro sucroferric oxyhydroxide Fresenius Medical Care North America NDA Current 49230-645 Velphoro sucroferric oxyhydroxide Fresenius Medical Care North America NDA Current 49230-645 Velphoro sucroferric oxyhydroxide Fresenius Medical Care North America NDA Current 49230-645 Velphoro sucroferric oxyhydroxide Fresenius Medical Care North America NDA Current 49230-645 Velphoro sucroferric oxyhydroxide Fresenius Medical Care North America NDA Current 49230-645 Velphoro sucroferric oxyhydroxide Fresenius Medical Care North America NDA Current 49230-645 Velphoro sucroferric oxyhydroxide Fresenius Medical Care North America NDA Current