Application 021381
- Type
- NDA
- Sponsor
- DENTSPLY PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XYLOCAINE DENTAL WITH EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | XYLOCAINE DENTAL WITH EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60026 | SUPPL | 2019-09-17 |