Application 019079
- Type
- NDA
- Sponsor
- EYEVANCE
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLAREX | FLUOROMETHOLONE ACETATE | SUSPENSION/DROPS;OPHTHALMIC | 0.1% | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0065-0096 | Flarex | fluorometholone acetate | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0096 | Flarex | fluorometholone acetate | Alcon Laboratories, Inc. | NDA | Current |
| 71776-100 | Flarex | fluorometholone acetate | Eyevance Pharmaceuticals | NDA | Current |
| 71776-100 | Flarex | fluorometholone acetate | Eyevance Pharmaceuticals | NDA | Current |
| 71776-100 | Flarex | fluorometholone acetate | Eyevance Pharmaceuticals | NDA | Current |
| 71776-100 | Flarex | fluorometholone acetate | Eyevance Pharmaceuticals | NDA | Current |