Application 089517
- Type
- ANDA
- Sponsor
- DENTSPLY PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POLOCAINE W/ LEVONORDEFRIN | LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.05MG/ML;2% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089517-001 | POLOCAINE W/ LEVONORDEFRIN | LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE | 0.05MG/ML;2% | INJECTABLE / INJECTION | 1988-04-14 |