Application 018268

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;450MG/100ML	No	No
002	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;220MG/100ML;450MG/100ML	No	No
003	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;450MG/100ML	No	No
004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;200MG/100ML	No	No
005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;220MG/100ML;200MG/100ML	No	No
006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;200MG/100ML	No	No
009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;200MG/100ML	No	No
010	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;450MG/100ML	No	No
011	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;330MG/100ML	No	No
012	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;330MG/100ML	No	No
013	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;220MG/100ML;330MG/100ML	No	No
014	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;330MG/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018268-001	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018268-002	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;220MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018268-003	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;300MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018268-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018268-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;220MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018268-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018268-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018268-010	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;75MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018268-011	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18
N018268-012	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18
N018268-013	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;220MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18
N018268-014	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18

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 2 of 14 · 528 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018268-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018268-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018268-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018268-010	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018268-011	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018268-012	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018268-013	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018268-014	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-001	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-002	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-003	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-010	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-011	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-012	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-013	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018268-014	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018268-001	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-002	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-003	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-010	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-011	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-012	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-013	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018268-014	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION		1986-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018268-001	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018268-002	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018268-003	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018268-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018268-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018268-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018268-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018268-010	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Application 018268

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#