Home Applications 022127 Application 022127
Type NDA
Sponsor SANOFI Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RENVELA SEVELAMER CARBONATE TABLET;ORAL 800MG Yes Yes
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 N022127-001 RENVELA SEVELAMER CARBONATE 800MG TABLET / ORAL RLD 2007-10-19
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 · 42 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 N022127-001 RENVELA 800MG TABLET / ORAL RLD 2007-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022127-001 RENVELA 800MG TABLET / ORAL AB RLD, RS 2007-10-19 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022127-001 7985418 2025-10-27 Drug product 2011-08-25 cb3db0bc1861…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022127-001 NPP 2019-11-25 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022127-001 NPP 2019-11-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022127-001 NPP 2019-11-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022127-001 NPP 2019-11-25 ea99ee380514…
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 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0955-1050 Sevelamer Carbonate Sevelamer Carbonate Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1050 Sevelamer Carbonate Sevelamer Carbonate Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1050 Sevelamer Carbonate Sevelamer Carbonate Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1050 Sevelamer Carbonate Sevelamer Carbonate Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1050 Sevelamer Carbonate Sevelamer Carbonate Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1050 Sevelamer Carbonate Sevelamer Carbonate Winthrop U.S. NDA AUTHORIZED GENERIC Current 17856-0130 Renvela SEVELAMER CARBONATE Atlantic Biologicals Corps NDA Current 58468-0130 Renvela SEVELAMER CARBONATE Genzyme Corporation NDA Current 58468-0130 Renvela SEVELAMER CARBONATE Genzyme Corporation NDA Current 58468-0130 Renvela SEVELAMER CARBONATE Genzyme Corporation NDA Current 58468-0130 Renvela SEVELAMER CARBONATE Genzyme Corporation NDA Current 58468-0130 Renvela SEVELAMER CARBONATE Genzyme Corporation NDA Current 58468-0130 Renvela SEVELAMER CARBONATE Genzyme Corporation NDA Current 58468-0130 Renvela SEVELAMER CARBONATE Genzyme Corporation NDA Current 58468-0130 Renvela SEVELAMER CARBONATE Genzyme Corporation NDA Current 68151-5113 Renvela SEVELAMER CARBONATE Carilion Materials Management NDA Current 70518-2490 Sevelamer Carbonate Sevelamer Carbonate REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-2490 Sevelamer Carbonate Sevelamer Carbonate REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-2490 Sevelamer Carbonate Sevelamer Carbonate REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current