Application 017995

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 60% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	60GM/100ML	No	No
002	DEXTROSE 60%	DEXTROSE	INJECTABLE;INJECTION	60GM/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	DEXTROSE	60GM/100ML	INJECTABLE / INJECTION		Approved before 1982
N017995-002	DEXTROSE 60%	DEXTROSE	60GM/100ML	INJECTABLE / INJECTION			1982-09-22

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017995-001	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017995-002	DEXTROSE 60%	60GM/100ML	INJECTABLE / INJECTION		1982-09-22	`3a93d1ddd44b…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Infant Dextrose	DEXTROSE	Henry Schein, Inc.	ce71d929-d11e-444c-bd45-e025d5172057	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: DEXTROSE
Dextrose	DEXTROSE	B. Braun Medical Inc.	60b6d7c3-0164-46c9-aa38-b5aa1c31a5d5	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: DEXTROSE
DEXTROSE	DEXTROSE	HF Acquisition Co. LLC. DBA HealthFirst	4d2d3d3d-d96e-4005-e063-6394a90afd9a	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: DEXTROSE
Dextrose	DEXTROSE	ICU Medical Inc.	b5cb7a5a-bbe8-4217-a82e-da818f7771c9	2025-11-02	Warnings, Adverse reactions	Name fallback generic name: DEXTROSE
Dextrose	DEXTROSE	B. Braun Medical Inc.	8ccb10fe-75a5-440b-8cd4-b11f4e98f7b0	2024-12-06	Warnings, Adverse reactions	Name fallback generic name: DEXTROSE
DEXTROSE	DEXTROSE	B. Braun Medical Inc.	085614c7-ada4-4e2c-87c0-c9bc2f18365a	2024-03-12	Warnings, Adverse reactions	Name fallback generic name: DEXTROSE
DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	75c902e8-50e7-a337-e053-2991aa0a2093	2024-02-19	Warnings, Adverse reactions	Name fallback generic name: DEXTROSE

Reported adverse events (FAERS/openFDA)#

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