Application 018931

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAVASOL 5.5% IN PLASTIC CONTAINER	AMINO ACIDS	INJECTABLE;INJECTION	5.5% (5.5GM/100ML)	No	No
002	TRAVASOL 8.5% IN PLASTIC CONTAINER	AMINO ACIDS	INJECTABLE;INJECTION	8.5% (8.5GM/100ML)	No	No
003	TRAVASOL 10% IN PLASTIC CONTAINER	AMINO ACIDS	INJECTABLE;INJECTION	10% (10MG/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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	AMINO ACIDS	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23
N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	AMINO ACIDS	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23
N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	AMINO ACIDS	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018931-003	TRAVASOL 10% IN PLASTIC CONTAINER	10% (10MG/100ML)	INJECTABLE / INJECTION	1984-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018931-001	TRAVASOL 5.5% IN PLASTIC CONTAINER	5.5% (5.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018931-002	TRAVASOL 8.5% IN PLASTIC CONTAINER	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	1984-08-23	`c0c555d07b60…`

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
Travasol	LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE	Baxter Healthcare Corporation	8543b5be-0f43-4891-9e56-d7c39fe839b5	2020-10-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018931 application number: NDA018931 ndc (product): 0338-0644

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0644	Travasol	Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine	Baxter Healthcare Corporation	NDA	Current
0338-0644	Travasol	Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine	Baxter Healthcare Corporation	NDA	Current
0338-0644	Travasol	Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine	Baxter Healthcare Corporation	NDA	Current
0338-0644	Travasol	Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine	Baxter Healthcare Corporation	NDA	Current
0338-0644	Travasol	Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine	Baxter Healthcare Corporation	NDA	Current
0338-0644	Travasol	Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64714	SUPPL	2020-09-29
64662	SUPPL	2020-09-24
50447	SUPPL	2017-11-17
50442	SUPPL	2017-11-17