FdaApplication
NDA 216190
Identifiers
- fda_app_no: NDA216190
Properties
| Property | Value |
|---|---|
| applicant_name | FIDELITY BIOPHARMA CO USA |
| application_type | NDA |
| approval_date | 2024-12-12 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ONTRALFY | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE/5ML | SOLUTION;ORAL |
1 product