Application 019216
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FML FORTE | FLUOROMETHOLONE | SUSPENSION/DROPS;OPHTHALMIC | 0.25% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 11980-228 | FML FORTE | fluorometholone | Allergan, Inc. | NDA | Current |
| 11980-228 | FML FORTE | fluorometholone | Allergan, Inc. | NDA | Current |
| 11980-228 | FML FORTE | fluorometholone | Allergan, Inc. | NDA | Current |
| 11980-228 | FML FORTE | fluorometholone | Allergan, Inc. | NDA | Current |