Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019216
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FML FORTE | FLUOROMETHOLONE | 0.25% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/13/2025 | SUPPL-30 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019216s030lbl.pdf | |
| 02/12/2013 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019216s025lbl.pdf | |
| 01/10/2006 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf | |
| 01/10/2006 | SUPPL-21 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf |