FdaApplication
NDA 209387
Identifiers
- fda_app_no: NDA209387
Properties
| Property | Value |
|---|---|
| applicant_name | EXELA PHARMA SCIENCES LLC |
| application_type | NDA |
| approval_date | 2017-03-08 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | 50MG/100ML (0.5MG/ML) | SOLUTION;INTRAVENOUS |
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | 20MG/100ML (0.2MG/ML) | SOLUTION;INTRAVENOUS |
3 products