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 2 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
2025-08-23 18:47 UTC	2025-08	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017493-004	TRAVASOL 5.5% W/O ELECTROLYTES	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017493-005	TRAVASOL 8.5% W/O ELECTROLYTES	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017493-006	TRAVASOL 10% W/O ELECTROLYTES	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017493-007	RENAMIN W/O ELECTROLYTES	6.5% (6.5GM/100ML)	INJECTABLE / INJECTION		1982-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017493-001	TRAVASOL 5.5% W/ ELECTROLYTES	5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017493-002	TRAVASOL 8.5% W/ ELECTROLYTES	8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017493-003	TRAVASOL 3.5% W/ ELECTROLYTES	3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`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
13155	SUPPL	2003-05-30
604	SUPPL	2003-01-17
603	SUPPL	2003-01-03