FdaApplication
NDA 215868
Identifiers
- fda_app_no: NDA215868
Properties
| Property | Value |
|---|---|
| applicant_name | EXELA PHARMA SCIENCES LLC |
| application_type | NDA |
| approval_date | 2022-07-20 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM | 100MG/100ML (1MG/ML) | SOLUTION;INTRAVENOUS |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM | 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
2 products