Application 217468
- Type
- ANDA
- Sponsor
- NAVINTA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIAZEPAM | DIAZEPAM | GEL;RECTAL | 2.5MG/0.5ML (5MG/ML) | No | No |
| 002 | DIAZEPAM | DIAZEPAM | GEL;RECTAL | 10MG/2ML (5MG/ML) | No | No |
| 003 | DIAZEPAM | DIAZEPAM | GEL;RECTAL | 20MG/4ML (5MG/ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84744 | ORIG | 2026-01-13 |