Application 016023
- Type
- NDA
- Sponsor
- ENDO PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | SYMMETREL | AMANTADINE HYDROCHLORIDE | SYRUP;ORAL | 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |