Application 019520

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	2.75%;5GM/100ML	No	No
002	TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	2.75%;10GM/100ML	No	No
003	TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	2.75%;15GM/100ML	No	No
004	TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	2.75%;20GM/100ML	No	No
005	TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	2.75%;25GM/100ML	No	No
006	TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;5GM/100ML	No	No
007	TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;10GM/100ML	No	No
008	TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;15GM/100ML	No	No
009	TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;20GM/100ML	No	No
010	TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;25GM/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 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N019520-001	TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	2.75%;5GM/100ML	INJECTABLE / INJECTION	1988-09-23
N019520-002	TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	2.75%;10GM/100ML	INJECTABLE / INJECTION	1988-09-23
N019520-003	TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	2.75%;15GM/100ML	INJECTABLE / INJECTION	1988-09-23
N019520-004	TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	2.75%;20GM/100ML	INJECTABLE / INJECTION	1988-09-23
N019520-005	TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	2.75%;25GM/100ML	INJECTABLE / INJECTION	1988-09-23
N019520-006	TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	4.25%;5GM/100ML	INJECTABLE / INJECTION	1988-09-23
N019520-007	TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-23
N019520-008	TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	4.25%;15GM/100ML	INJECTABLE / INJECTION	1988-09-23
N019520-009	TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-23
N019520-010	TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-23

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 3 of 11 · 440 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019520-001	TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER	2.75%;5GM/100ML	INJECTABLE / INJECTION	1988-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019520-002	TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER	2.75%;10GM/100ML	INJECTABLE / INJECTION	1988-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019520-003	TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER	2.75%;15GM/100ML	INJECTABLE / INJECTION	1988-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019520-004	TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER	2.75%;20GM/100ML	INJECTABLE / INJECTION	1988-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019520-005	TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER	2.75%;25GM/100ML	INJECTABLE / INJECTION	1988-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019520-006	TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER	4.25%;5GM/100ML	INJECTABLE / INJECTION	1988-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019520-007	TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019520-008	TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER	4.25%;15GM/100ML	INJECTABLE / INJECTION	1988-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019520-009	TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019520-010	TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019520-001	TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER	2.75%;5GM/100ML	INJECTABLE / INJECTION	1988-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019520-002	TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER	2.75%;10GM/100ML	INJECTABLE / INJECTION	1988-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019520-003	TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER	2.75%;15GM/100ML	INJECTABLE / INJECTION	1988-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019520-004	TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER	2.75%;20GM/100ML	INJECTABLE / INJECTION	1988-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019520-005	TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER	2.75%;25GM/100ML	INJECTABLE / INJECTION	1988-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019520-006	TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER	4.25%;5GM/100ML	INJECTABLE / INJECTION	1988-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019520-007	TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019520-008	TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER	4.25%;15GM/100ML	INJECTABLE / INJECTION	1988-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019520-009	TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019520-010	TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019520-001	TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER	2.75%;5GM/100ML	INJECTABLE / INJECTION	1988-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019520-002	TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER	2.75%;10GM/100ML	INJECTABLE / INJECTION	1988-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019520-003	TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER	2.75%;15GM/100ML	INJECTABLE / INJECTION	1988-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019520-004	TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER	2.75%;20GM/100ML	INJECTABLE / INJECTION	1988-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019520-005	TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER	2.75%;25GM/100ML	INJECTABLE / INJECTION	1988-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019520-006	TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER	4.25%;5GM/100ML	INJECTABLE / INJECTION	1988-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019520-007	TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019520-008	TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER	4.25%;15GM/100ML	INJECTABLE / INJECTION	1988-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019520-009	TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019520-010	TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019520-001	TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER	2.75%;5GM/100ML	INJECTABLE / INJECTION	1988-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019520-002	TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER	2.75%;10GM/100ML	INJECTABLE / INJECTION	1988-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019520-003	TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER	2.75%;15GM/100ML	INJECTABLE / INJECTION	1988-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019520-004	TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER	2.75%;20GM/100ML	INJECTABLE / INJECTION	1988-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019520-005	TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER	2.75%;25GM/100ML	INJECTABLE / INJECTION	1988-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019520-006	TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER	4.25%;5GM/100ML	INJECTABLE / INJECTION	1988-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019520-007	TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019520-008	TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER	4.25%;15GM/100ML	INJECTABLE / INJECTION	1988-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019520-009	TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019520-010	TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-23	`d8e5a09893c0…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17429	SUPPL	2000-04-12