Application 017493

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAVASOL 5.5% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	No	No
002	TRAVASOL 8.5% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	No	No
003	TRAVASOL 3.5% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	No	No
004	TRAVASOL 5.5% W/O ELECTROLYTES	AMINO ACIDS	INJECTABLE;INJECTION	5.5% (5.5GM/100ML)	No	No
005	TRAVASOL 8.5% W/O ELECTROLYTES	AMINO ACIDS	INJECTABLE;INJECTION	8.5% (8.5GM/100ML)	No	No
006	TRAVASOL 10% W/O ELECTROLYTES	AMINO ACIDS	INJECTABLE;INJECTION	10% (10GM/100ML)	No	No
007	RENAMIN W/O ELECTROLYTES	AMINO ACIDS	INJECTABLE;INJECTION	6.5% (6.5GM/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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	AMINO ACIDS	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982
N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	AMINO ACIDS	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982
N017493-006	TRAVASOL 10% W/O ELECTROLYTES	AMINO ACIDS	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982
N017493-007	RENAMIN W/O ELECTROLYTES	AMINO ACIDS	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15

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 8 · 308 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	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`

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
13155	SUPPL	2003-05-30
604	SUPPL	2003-01-17
603	SUPPL	2003-01-03