Application 216190
- Type
- NDA
- Sponsor
- FIDELITY BIOPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONTRALFY | TIZANIDINE HYDROCHLORIDE | SOLUTION;ORAL | EQ 2MG BASE/5ML | Yes | Yes |
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONTRALFY | TIZANIDINE HYDROCHLORIDE | SOLUTION;ORAL | EQ 2MG BASE/5ML | Yes | Yes |