FdaApplication
NDA 020140
Identifiers
- fda_app_no: NDA020140
Properties
| Property | Value |
|---|---|
| applicant_name | ACROTECH BIOPHARMA INC |
| application_type | NDA |
| approval_date | 2008-03-07 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FUSILEV | LEVOLEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | POWDER;INTRAVENOUS |
| FUSILEV | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
| FUSILEV | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
3 products