Application 019018
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TROPHAMINE | AMINO ACIDS | INJECTABLE;INJECTION | 6% (6GM/100ML) | Yes | Yes |
| 003 | TROPHAMINE 10% | AMINO ACIDS | INJECTABLE;INJECTION | 10% (10GM/100ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019018-001 | TROPHAMINE | AMINO ACIDS | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | |
| N019018-003 | TROPHAMINE 10% | AMINO ACIDS | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 |
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 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1984-07-20 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1988-09-07 | 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 |
|---|---|---|---|---|---|---|
| TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINE | B. Braun Medical Inc. | cb6d23ff-3ec5-445a-acbe-f88fd57949bf | 2026-08-19 | Warnings, Adverse reactions | 019018 NDA019018 0264-1933 |
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 |
|---|---|---|---|---|---|
| 0264-1933 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |
| 0264-1933 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |
| 0264-1933 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |
| 0264-9341 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |
| 0264-9341 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |
| 0264-9341 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |
| 0264-9341 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |
| 0264-9361 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |
| 0264-9361 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |
| 0264-9361 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |
| 0264-9361 | TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | B. Braun Medical Inc. | NDA | Current |