Application 019626

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 2.5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	2.5GM/100ML	No	No
002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	5GM/100ML	Yes	Yes
003	DEXTROSE 7.7% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	7.7GM/100ML	No	No
004	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	10GM/100ML	Yes	Yes
005	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	70GM/100ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	RLD / RS	Approval date
N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	DEXTROSE	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02
N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02
N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	DEXTROSE	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02
N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02
N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019626-002	AP
N019626-004	AP
N019626-005	AP

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 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019626-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019626-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019626-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019626-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019626-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019626-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019626-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019626-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019626-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019626-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019626-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019626-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019626-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019626-004	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019626-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019626-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019626-004	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019626-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019626-002	AP	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextrose	DEXTROSE	B. Braun Medical Inc.	8ccb10fe-75a5-440b-8cd4-b11f4e98f7b0	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019626 application number: NDA019626 ndc (product): 0264-7387
DEXTROSE	DEXTROSE	B. Braun Medical Inc.	085614c7-ada4-4e2c-87c0-c9bc2f18365a	2024-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019626 application number: NDA019626 ndc (product): 0264-7510 ndc (product): 0264-7520

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-7387	Dextrose	Dextrose	B. Braun Medical Inc.	NDA	Current
0264-7387	Dextrose	Dextrose	B. Braun Medical Inc.	NDA	Current
0264-7387	Dextrose	Dextrose	B. Braun Medical Inc.	NDA	Current
0264-7510	DEXTROSE	DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-7510	DEXTROSE	DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-7520	DEXTROSE	DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-7520	DEXTROSE	DEXTROSE	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33815	SUPPL	2015-02-20
33814	SUPPL	2004-04-05
17489	SUPPL	2004-03-02