Application 020849
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER | AMINO ACIDS | INJECTABLE;INJECTION | 20% (20GM/100ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020849-001 | PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER | AMINO ACIDS | 20% (20GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1998-08-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N020849-001 | PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER | 20% (20GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1998-08-26 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ProSol | VALINE, LYSINE, HISTIDINE, ISOLEUCINE, LEUCINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Baxter Healthcare Corporation | cc2ace81-5881-43f1-ba94-41b674adc2fc | 2020-10-07 | Warnings, Adverse reactions | 020849 NDA020849 0338-0499 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0499 | ProSol | Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine | Baxter Healthcare Corporation | NDA | Current |
| 0338-0499 | ProSol | Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine | Baxter Healthcare Corporation | NDA | Current |
| 0338-0499 | ProSol | Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine | Baxter Healthcare Corporation | NDA | Current |
| 0338-0499 | ProSol | Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine | Baxter Healthcare Corporation | NDA | Current |
| 0338-0499 | ProSol | Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine | Baxter Healthcare Corporation | NDA | Current |
| 0338-0499 | ProSol | Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine | Baxter Healthcare Corporation | NDA | Current |