Application 207026

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 207026 application number: NDA207026 ndc (product): 24571-117 ndc (product): 24571-116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
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 table
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