Home Applications 022581 Application 022581
Type NDA
Sponsor FRESENIUS MEDCL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PHOSLYRA CALCIUM ACETATE SOLUTION;ORAL 667MG/5ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N022581-001 PHOSLYRA CALCIUM ACETATE 667MG/5ML SOLUTION / ORAL RLD 2011-04-18
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 N022581-001 8592480 2027-07-20 U-1469 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 N022581-001 8591938 2030-02-23 U-1469 Drug product
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 · 43 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 2026-09-14 22:38:34 2026-08 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD 2011-04-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022581-001 PHOSLYRA 667MG/5ML SOLUTION / ORAL RLD, RS 2011-04-18 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022581-001 8592480 2027-07-20 U-1469 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022581-001 8591938 2030-02-23 U-1469 Drug product 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022581-001 8592480 2027-07-20 U-1469 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022581-001 8591938 2030-02-23 U-1469 Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022581-001 8592480 2027-07-20 U-1469 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022581-001 8591938 2030-02-23 U-1469 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022581-001 8592480 2027-07-20 U-1469 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022581-001 8591938 2030-02-23 U-1469 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022581-001 8592480 2027-07-20 U-1469 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022581-001 8591938 2030-02-23 U-1469 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022581-001 8592480 2027-07-20 U-1469 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022581-001 8591938 2030-02-23 U-1469 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022581-001 8592480 2027-07-20 U-1469 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022581-001 8591938 2030-02-23 U-1469 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022581-001 8592480 2027-07-20 U-1469 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022581-001 8591938 2030-02-23 U-1469 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022581-001 8592480 2027-07-20 U-1469 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022581-001 8591938 2030-02-23 U-1469 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022581-001 8592480 2027-07-20 U-1469 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022581-001 8591938 2030-02-23 U-1469 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022581-001 8592480 2027-07-20 U-1469 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022581-001 8591938 2030-02-23 U-1469 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022581-001 8592480 2027-07-20 U-1469 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022581-001 8591938 2030-02-23 U-1469 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022581-001 8592480 2027-07-20 U-1469 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022581-001 9089528 2027-07-20 U-1469 2015-08-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022581-001 8591938 2030-02-23 U-1469 Drug product 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022581-001 8592480 2027-07-20 U-1469 301d65b070ca…
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 2 of 2 · 22 matching rows.
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 49230-643 Phoslyra calcium acetate Fresenius Medical Care North America NDA Current 49230-643 Phoslyra calcium acetate Fresenius Medical Care North America NDA Current 49230-643 Phoslyra calcium acetate Fresenius Medical Care North America NDA Current 49230-643 Phoslyra calcium acetate Fresenius Medical Care North America NDA Current 49230-643 Phoslyra calcium acetate Fresenius Medical Care North America NDA Current 49230-643 Phoslyra calcium acetate Fresenius Medical Care North America NDA Current 49230-643 Phoslyra calcium acetate Fresenius Medical Care North America NDA Current 49230-643 Phoslyra calcium acetate Fresenius Medical Care North America NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 64813 SUPPL 2020-10-02 64777 SUPPL 2020-10-01 38865 SUPPL 2015-05-04 29888 SUPPL 2015-05-04 44785 ORIG 2011-10-20 22067 ORIG 2011-10-20 17745 ORIG 2011-04-21 7569 ORIG 2011-04-20