Application 020577

Type: NDA
Sponsor: LUKARE MEDICAL LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELLIOTTS B SOLUTION	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INJECTABLE;INTRATHECAL	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	Yes	Yes

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

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
N020577-001	ELLIOTTS B SOLUTION	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL		RLD, RS	1996-09-27

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 · 42 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	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020577-001	ELLIOTTS B SOLUTION	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML	INJECTABLE / INTRATHECAL	RLD, RS	1996-09-27	`e64feba35796…`

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
Elliotts B	SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE	Lukare Medical, LLC	08036dbd-55b3-47b9-9890-000f253544f3	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020577 application number: NDA020577 ndc (product): 55792-007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55792-007	Elliotts B	sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate	Lukare Medical, LLC	NDA	Current
67871-007	Elliotts B	sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate	QOL Medical, LLC	NDA	Current