Application 019976
- Type
- NDA
- Sponsor
- FRESENIUS MEDCL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHOSLO | CALCIUM ACETATE | TABLET;ORAL | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019976-001 | PHOSLO | CALCIUM ACETATE | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 |
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.
| 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UTC | 2026-02 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019976-001 | PHOSLO | 667MG | TABLET / ORAL | RLD | 1990-12-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019976-001 | PHOSLO | 667MG | TABLET / ORAL | RLD | 1990-12-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1990-12-10 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1990-12-10 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1990-12-10 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1990-12-10 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1990-12-10 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1990-12-10 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1990-12-10 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1990-12-10 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1990-12-10 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019976-001 | PHOSLO | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1990-12-10 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Calcium Acetate | CALCIUM ACETATE | American Health Packaging | 2072d9f4-abb1-4699-bde5-6041dd79cad5 | 2026-06-04 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | AvPAK | 52e35dd6-db95-98e6-e063-6294a90ab801 | 2026-05-28 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | Rising Pharma Holdings, Inc. | ce650ba5-fb42-e444-e053-2a95a90a075a | 2026-05-15 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | NCS HealthCare of KY, LLC dba Vangard Labs | 7177829c-bd89-485c-b5e3-15e457e969c5 | 2026-04-17 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | Cardinal Health 107, LLC | a23b6070-eb4b-48e3-b563-8232206a6be4 | 2026-04-15 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | Major Pharmaceuticals | 9a731cdf-6488-44ca-b97f-512a0e9deab1 | 2026-03-17 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | Westminster Pharmaceuticals, LLC | 1195f5d5-db91-4b9e-86ad-be340b43d690 | 2026-02-24 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | American Health Packaging | 1090762c-eec1-4ab0-9ddc-43caa764cd0e | 2026-01-08 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | PD-Rx Pharmaceuticals, Inc. | 925918d5-9f89-4f2f-9bb9-d9c53d90bb0a | 2025-10-14 | Warnings, Adverse reactions | CALCIUM ACETATE |
| calcium acetate | CALCIUM ACETATE | REMEDYREPACK INC. | 89a2ee04-1024-4a81-ba0d-a6655d529827 | 2025-10-02 | Warnings, Adverse reactions | CALCIUM ACETATE |
| calcium acetate | CALCIUM ACETATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | d48c66a9-26fe-4e1a-a68a-88afe83fb51d | 2025-07-01 | Warnings, Adverse reactions | CALCIUM ACETATE |
| calcium acetate | CALCIUM ACETATE | AvKARE | 35a6f515-dfe7-031c-e063-6294a90a5e95 | 2025-06-04 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | Proficient Rx LP | 80c15366-9420-41c2-8817-b9c39ddfcec1 | 2025-06-01 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | Hikma Pharmaceuticals USA Inc. | 85fd41f8-2823-44ca-a15e-f1f2e5d0ff94 | 2025-04-17 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | Chartwell RX LLC | 9584350a-b6ad-45ae-b1c5-c8ca8f471c03 | 2024-10-14 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | Nivagen Pharmaceuticals, Inc. | da6dc42d-1ae6-45ff-8a81-20a7135f8d17 | 2023-12-05 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | Chartwell RX, LLC. | 781c3f1f-b622-418b-8c0e-3407e9b90656 | 2023-10-03 | Warnings, Adverse reactions | CALCIUM ACETATE |
| CALCIUM ACETATE | CALCIUM ACETATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ac4975aa-0ee9-4473-81e2-839f1556e684 | 2023-07-28 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | SQUARE PHARMACEUTICALS LIMITED | 5af79d16-31ad-4d68-9a6d-bb5d9c91535d | 2023-07-03 | Warnings, Adverse reactions | CALCIUM ACETATE |
| Calcium Acetate | CALCIUM ACETATE | Cipla USA Inc., | 000c044a-12ef-4484-942e-99552b777d58 | 2021-06-01 | Warnings, Adverse reactions | CALCIUM ACETATE |