Application 075880
- Type
- ANDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREMASOL 6% IN PLASTIC CONTAINER | AMINO ACIDS | INJECTABLE;INJECTION | 6% (6GM/100ML) | No | No |
| 002 | PREMASOL 10% IN PLASTIC CONTAINER | AMINO ACIDS | INJECTABLE;INJECTION | 10% (10GM/100ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | AMINO ACIDS | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | ||
| A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | AMINO ACIDS | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075880-001 | PREMASOL 6% IN PLASTIC CONTAINER | 6% (6GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075880-002 | PREMASOL 10% IN PLASTIC CONTAINER | 10% (10GM/100ML) | INJECTABLE / INJECTION | 2003-06-19 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Company | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 2022-08-04 | Boxed warning, Warnings, Adverse reactions | 075880 ANDA075880 0338-1131 0338-1130 |
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 |
|---|---|---|---|---|---|
| 0338-1130 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1130 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1130 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1130 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1130 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1130 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1130 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1131 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1131 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1131 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1131 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1131 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |
| 0338-1131 | Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | ANDA | Current |