Application 206307
- Type
- NDA
- Sponsor
- MERLION PHARMS GMBH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XTORO | FINAFLOXACIN | SUSPENSION/DROPS;OTIC | 0.3% | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85488 | SUPPL | 2026-03-24 |
| 85423 | SUPPL | 2026-03-20 |
| 85422 | SUPPL | 2026-03-20 |
| 44941 | ORIG | 2015-01-14 |
| 43513 | ORIG | 2015-01-14 |
| 19713 | ORIG | 2014-12-19 |
| 10556 | ORIG | 2014-12-19 |
| 63919 | ORIG | 1900-01-01 |
| 51108 | ORIG | 1900-01-01 |
| 51107 | ORIG | 1900-01-01 |
| 51106 | ORIG | 1900-01-01 |