Application 018931
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | a50c72e98297… |
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.
| 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 | 018931 NDA018931 0338-0644 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |