Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019079
Company: HARROW EYE
Company: HARROW EYE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLAREX | FLUOROMETHOLONE ACETATE | 0.1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/23/2025 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019079s041lbl.pdf | |
| 08/02/2022 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019079s033lbl.pdf | |
| 10/24/2016 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019079s030lbl.pdf | |
| 11/08/2006 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019079s024lbl.pdf |