Drug application
TRALEMENT (CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID and 1 more)
Drugs@FDA NDA 209376 · AM REGENT
Key facts
| Drug name | TRALEMENT |
|---|---|
| Active ingredients | CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID, ZINC SULFATE |
| Application type | NDA |
| Application number | 209376 |
| Company | AM REGENT |
| Dosage forms | SOLUTION, INTRAVENOUS |
| Strength | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML) |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Jul 2, 2020 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: