Skip to contentApplication 216755
- Type
- NDA
- Sponsor
- SAPTALIS PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LIKMEZ | METRONIDAZOLE | SUSPENSION;ORAL | 500MG/5ML | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81418 | SUPPL | 2025-03-04 |
| 81417 | SUPPL | 2025-03-04 |
| 79014 | SUPPL | 2024-07-09 |
| 79000 | SUPPL | 2024-07-09 |
| 78468 | SUPPL | 2024-05-15 |
| 78467 | SUPPL | 2024-05-15 |
| 77189 | ORIG | 2024-01-04 |
| 75553 | ORIG | 2023-10-03 |
| 75558 | ORIG | 2023-09-25 |