Application 084048
- Type
- ANDA
- Sponsor
- SEPTODONT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OCTOCAINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.01MG/ML;2% | No | No |
| 002 | OCTOCAINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML;2% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A084048-001 | OCTOCAINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.01MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | ||
| A084048-002 | OCTOCAINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.02MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 |