Application 018030

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;450MG/100ML	No	No
002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;450MG/100ML	No	No
003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;330MG/100ML	No	No
004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;200MG/100ML	No	No
005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;110MG/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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982

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 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

Application 018030

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#