Application 018744

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML	No	No
002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML	No	No
003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;220MG/100ML	No	No
004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09
N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09
N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09
N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018744-001	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	1982-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018744-002	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	1982-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018744-003	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;220MG/100ML	INJECTABLE / INJECTION	1982-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018744-004	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	1982-11-09	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

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

Application 018744

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#