FdaApplication
NDA 204300
Identifiers
- fda_app_no: NDA204300
Properties
| Property | Value |
|---|---|
| applicant_name | EXELA PHARMA SCIENCES LLC |
| application_type | NDA |
| approval_date | 2014-06-27 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
| VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
| VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
3 products