Application 216564
- Type
- NDA
- Sponsor
- DEPROCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLAVALTA | EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE | SOLUTION;INJECTION | EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML) | Yes | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85461 | ORIG | 2026-03-23 |