Application 021384
- Type
- NDA
- Sponsor
- DENTSPLY PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DURANEST | EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |