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| INJECTABLE;INJECTION | 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021384-001 | DURANEST | EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |