Application 207026
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | INJECTABLE;INJECTION | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | Yes | Yes |
| 002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | INJECTABLE;INJECTION | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | |
| N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N207026-001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N207026-002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | INJECTABLE / INJECTION | RLD, RS | 2015-01-13 | 74a2ff9319b5… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207026-001 | ODE-85 | 2022-01-13 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207026-002 | ODE-85 | 2022-01-13 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N207026-001 | ODE-85 | 2022-01-13 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N207026-002 | ODE-85 | 2022-01-13 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N207026-001 | ODE-85 | 2022-01-13 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N207026-002 | ODE-85 | 2022-01-13 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N207026-001 | ODE-85 | 2022-01-13 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N207026-002 | ODE-85 | 2022-01-13 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N207026-001 | ODE-85 | 2022-01-13 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N207026-002 | ODE-85 | 2022-01-13 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N207026-001 | ODE-85 | 2022-01-13 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N207026-002 | ODE-85 | 2022-01-13 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N207026-001 | ODE-85 | 2022-01-13 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N207026-002 | ODE-85 | 2022-01-13 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N207026-001 | ODE-85 | 2022-01-13 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N207026-002 | ODE-85 | 2022-01-13 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N207026-001 | ODE-85 | 2022-01-13 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N207026-002 | ODE-85 | 2022-01-13 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N207026-001 | ODE-85 | 2022-01-13 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N207026-002 | ODE-85 | 2022-01-13 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N207026-001 | ODE-85 | 2022-01-13 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N207026-002 | ODE-85 | 2022-01-13 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N207026-001 | ODE-85 | 2022-01-13 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N207026-002 | ODE-85 | 2022-01-13 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N207026-001 | ODE-85 | 2022-01-13 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N207026-002 | ODE-85 | 2022-01-13 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | N207026-001 | ODE-85 | 2022-01-13 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N207026-002 | ODE-85 | 2022-01-13 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N207026-001 | ODE-85 | 2022-01-13 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N207026-002 | ODE-85 | 2022-01-13 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N207026-001 | ODE-85 | 2022-01-13 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N207026-002 | ODE-85 | 2022-01-13 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N207026-001 | ODE-85 | 2022-01-13 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N207026-002 | ODE-85 | 2022-01-13 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N207026-001 | ODE-85 | 2022-01-13 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N207026-002 | ODE-85 | 2022-01-13 | 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 |
|---|---|---|---|---|---|---|
| PRISMASOL BGK2/0 | MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE | Vantive US Healthcare LLC | 7f675fee-8940-4ece-bb0c-75ac79d8708c | 2025-05-31 | Warnings, Adverse reactions | 207026 NDA207026 24571-117 24571-116 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24571-116 | PHOXILLUM | calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-116 | PHOXILLUM | calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-116 | PHOXILLUM | calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-116 | PHOXILLUM | calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-116 | PHOXILLUM | calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-116 | PHOXILLUM | calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-116 | PHOXILLUM | calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-117 | PHOXILLUM | magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-117 | PHOXILLUM | magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-117 | PHOXILLUM | magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-117 | PHOXILLUM | magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-117 | PHOXILLUM | magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-117 | PHOXILLUM | magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
| 24571-117 | PHOXILLUM | magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate | Baxter Healthcare Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74162 | SUPPL | 2023-05-03 |
| 74156 | SUPPL | 2023-05-03 |
| 56243 | SUPPL | 2018-12-06 |
| 56296 | SUPPL | 2018-11-06 |
| 48904 | SUPPL | 2017-07-05 |
| 48891 | SUPPL | 2017-07-03 |
| 32839 | SUPPL | 2016-07-22 |
| 19955 | SUPPL | 2016-07-21 |
| 19954 | SUPPL | 2015-12-17 |
| 10608 | SUPPL | 2015-12-17 |
| 44954 | ORIG | 2015-04-07 |
| 43530 | ORIG | 2015-04-07 |
| 10607 | ORIG | 2015-01-15 |
| 40577 | ORIG | 2015-01-14 |