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 45 .
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 N205109-001 VELPHORO FERRIC OXYHYDROXIDE EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 N205109-002 VELPHORO FERRIC OXYHYDROXIDE EQ 250MG IRON TABLET, CHEWABLE / ORAL RLD 2026-10-13
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 · 4 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 2 · 46 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 2026-11-14 07:37:17 2026-10 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-002 VELPHORO EQ 250MG IRON TABLET, CHEWABLE / ORAL RLD 2026-10-13 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205109-001 VELPHORO EQ 500MG IRON TABLET, CHEWABLE / ORAL RLD, RS 2013-11-27 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 21 · 816 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-11-14 07:37:17 2026-10 N205109-001 10682376 2028-11-13 Drug product 2020-06-17 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10695367 2028-11-13 Drug product 2020-07-01 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10925896 2028-11-13 Drug product 2021-03-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10925897 2028-11-13 Drug product 2021-03-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10933090 2028-11-13 Drug product 2021-03-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11013761 2028-11-13 Drug product 2021-06-02 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11013762 2028-11-13 Drug product 2021-06-02 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10682376*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10695367*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10925896*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10925897*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10933090*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11013761*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11013762*PED 2029-05-13 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 9561251 2030-01-23 U-1468 Drug product 2017-03-02 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 9561251*PED 2030-07-23 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10624855 2034-11-26 Drug product 2020-04-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11234938 2034-11-26 Drug product 2022-02-17 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11446252 2034-11-26 Drug product 2022-09-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 10624855*PED 2035-05-26 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11234938*PED 2035-05-26 Pediatric extension d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N205109-001 11446252*PED 2035-05-26 Pediatric extension d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N205109-001 10682376 2028-11-13 Drug product 2020-06-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10695367 2028-11-13 Drug product 2020-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10925896 2028-11-13 Drug product 2021-03-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10925897 2028-11-13 Drug product 2021-03-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10933090 2028-11-13 Drug product 2021-03-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 11013761 2028-11-13 Drug product 2021-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 11013762 2028-11-13 Drug product 2021-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10682376*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10695367*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10925896*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10925897*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10933090*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 11013761*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 11013762*PED 2029-05-13 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 9561251 2030-01-23 U-1468 Drug product 2017-03-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 9561251*PED 2030-07-23 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 10624855 2034-11-26 Drug product 2020-04-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205109-001 11234938 2034-11-26 Drug product 2022-02-17 c2088c7a36db…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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