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 5 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
2023-12-20 04:57 UTC	2023-12	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`

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)#