FdaApplication
NDA 209376
Identifiers
- fda_app_no: NDA209376
Properties
| Property | Value |
|---|---|
| applicant_name | AMERICAN REGENT INC |
| application_type | NDA |
| approval_date | 2020-07-02 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MULTRYS | CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE | EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML) | SOLUTION;INTRAVENOUS |
| TRALEMENT | CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML) | SOLUTION;INTRAVENOUS |
| TRALEMENT | CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML) | SOLUTION;INTRAVENOUS |
3 products