Application 017521

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 50% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	50GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	DEXTROSE 40% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	40GM/100ML	Yes	No
003	DEXTROSE 30% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	30GM/100ML	Yes	No
004	DEXTROSE 20% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	20GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	DEXTROSE 60% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	60GM/100ML	Yes	No
006	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	70GM/100ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N017521-001	DEXTROSE 50% IN PLASTIC CONTAINER	DEXTROSE	50GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N017521-002	DEXTROSE 40% IN PLASTIC CONTAINER	DEXTROSE	40GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N017521-003	DEXTROSE 30% IN PLASTIC CONTAINER	DEXTROSE	30GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N017521-004	DEXTROSE 20% IN PLASTIC CONTAINER	DEXTROSE	20GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N017521-005	DEXTROSE 60% IN PLASTIC CONTAINER	DEXTROSE	60GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26
N017521-006	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	70GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26

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 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N017521-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017521-002	DEXTROSE 40% IN PLASTIC CONTAINER	40GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017521-003	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017521-004	DEXTROSE 20% IN PLASTIC CONTAINER	20GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017521-005	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017521-006	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017521-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017521-002	DEXTROSE 40% IN PLASTIC CONTAINER	40GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017521-003	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017521-004	DEXTROSE 20% IN PLASTIC CONTAINER	20GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017521-005	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017521-006	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017521-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017521-002	DEXTROSE 40% IN PLASTIC CONTAINER	40GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017521-003	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017521-004	DEXTROSE 20% IN PLASTIC CONTAINER	20GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017521-005	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017521-006	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017521-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017521-002	DEXTROSE 40% IN PLASTIC CONTAINER	40GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017521-003	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017521-004	DEXTROSE 20% IN PLASTIC CONTAINER	20GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017521-005	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017521-006	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017521-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017521-002	DEXTROSE 40% IN PLASTIC CONTAINER	40GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017521-003	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017521-004	DEXTROSE 20% IN PLASTIC CONTAINER	20GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017521-005	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017521-006	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017521-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017521-002	DEXTROSE 40% IN PLASTIC CONTAINER	40GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017521-003	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017521-004	DEXTROSE 20% IN PLASTIC CONTAINER	20GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017521-005	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017521-006	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017521-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017521-002	DEXTROSE 40% IN PLASTIC CONTAINER	40GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017521-003	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017521-004	DEXTROSE 20% IN PLASTIC CONTAINER	20GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`fd3edfee7708…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	N017521-006	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017521-006	AP	1	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXTROSE	DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	0332f34a-7038-47cc-ba59-d55cad6b73ca	2019-08-05	Warnings, Adverse reactions	Exact identifier ndc (product): 0338-0719

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0719	Dextrose	Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53056	SUPPL	2018-03-19
52981	SUPPL	2018-03-15
11007	SUPPL	2015-01-09
615	SUPPL	2014-12-24
40745	SUPPL	2007-09-24
20075	SUPPL	2007-09-24
13165	SUPPL	2003-07-31
614	SUPPL	2003-07-31