FdaApplication
NDA 215252
Identifiers
- fda_app_no: NDA215252
Properties
| Property | Value |
|---|---|
| applicant_name | EXELA PHARMA SCIENCES LLC |
| application_type | NDA |
| approval_date | 2021-10-28 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% | DILTIAZEM HYDROCHLORIDE | 125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
| DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% | DILTIAZEM HYDROCHLORIDE | 250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
2 products