Application 212121
- Type
- NDA
- Sponsor
- CMP DEV LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | SOLUTION;INTRAVENOUS | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N212121-001 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2019-09-19 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 |
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 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2019-09-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2019-09-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2019-09-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2019-09-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2019-09-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2019-09-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2019-09-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2019-09-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N212121-001 | POTASSIUM PHOSPHATES | 4500MG/15ML (300MG/ML);2650MG/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 3f01610625f2… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-09-19 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212121-001 | POTASSIUM PHOSPHATES | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2019-09-19 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212121-001 | 10632150 | 2039-04-19 | U-2789 | Drug product | 2020-05-04 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Potassium Phosphates | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC | CIVICA, INC. | f7702b2f-d0d1-4696-896d-571607fc0dc8 | 2026-07-10 | Warnings, Adverse reactions | Potassium Phosphates |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATES | GLENMARK PHARMACEUTICALS INC., USA | 70c7710c-a354-4941-bd46-e64d6ea6b5dc | 2026-03-20 | Warnings, Adverse reactions | POTASSIUM PHOSPHATES |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATES | Caplin Steriles Limited | fbbd8380-9848-4862-8c73-2f53fcdf7120 | 2026-03-16 | Warnings, Adverse reactions | POTASSIUM PHOSPHATES |
| Potassium Phosphates | POTASSIUM PHOSPHATES | Hospira, Inc. | 2fcbc814-c7a4-469a-8b1d-6819b961bfb9 | 2025-09-30 | Warnings, Adverse reactions | Potassium Phosphates |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATES IN SODIUM CHLORIDE | Amneal Pharmaceuticals LLC | dce22c93-aa48-48a9-ac8b-716400d33c9e | 2025-09-01 | Warnings, Adverse reactions | POTASSIUM PHOSPHATES |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, | Amneal Pharmaceuticals Private Limited | 125121b8-bc4c-44ee-906e-e72f652a5aa6 | 2025-04-30 | Warnings, Adverse reactions | POTASSIUM PHOSPHATES |
| Potassium Phosphates | POTASSIUM PHOSPHATES | Fresenius Kabi USA, LLC | 357c3020-ea6f-4401-a2e7-cebb82b03144 | 2025-04-15 | Warnings, Adverse reactions | Potassium Phosphates |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, | Amneal Pharmaceuticals Private Limited | 98315c6e-308d-423b-a046-4be1f54d30ae | 2025-04-14 | Warnings, Adverse reactions | POTASSIUM PHOSPHATES |
| Potassium Phosphates | POTASSIUM PHOSPHATES | Cipla USA Inc. | f1f26a17-d2e2-48f5-9054-8ee7e380556e | 2025-02-28 | Warnings, Adverse reactions | Potassium Phosphates |
| Potassium Phosphates | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC | Fresenius Kabi USA, LLC | 475f5cd7-45bd-412a-b419-9962585d6cda | 2025-02-28 | Warnings, Adverse reactions | Potassium Phosphates |
| Potassium Phosphates | POTASSIUM PHOSPHATES | American Regent, Inc. | 41a85cca-c463-4f39-9335-177b04c290a9 | 2025-02-07 | Warnings, Adverse reactions | Potassium Phosphates |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, | Amneal Pharmaceuticals Private Limited | 89136c51-a60b-4269-bd05-9489f060a734 | 2024-12-31 | Warnings, Adverse reactions | POTASSIUM PHOSPHATES |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 46287-024 | POTASSIUM PHOSPHATES | monobasic potassium phosphate and dibasic potassium phosphate | CMP PHARMA, INC. | NDA | Current |
| 46287-024 | POTASSIUM PHOSPHATES | monobasic potassium phosphate and dibasic potassium phosphate | CMP PHARMA, INC. | NDA | Current |