FdaApplication
NDA 208193
Identifiers
- fda_app_no: NDA208193
Properties
| Property | Value |
|---|---|
| applicant_name | ROSEMONT PHARMACEUTICALS LLC |
| application_type | NDA |
| approval_date | 2019-09-18 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OZOBAX | BACLOFEN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL |
| OZOBAX DS | BACLOFEN | 10MG/5ML | SOLUTION;ORAL |
2 products