Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019525
Company: ALLERGAN
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FML-S | FLUOROMETHOLONE; SULFACETAMIDE SODIUM | 0.1%;10% | SUSPENSION/DROPS;OPHTHALMIC | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/10/2005 | SUPPL-10 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19525S010lbl.pdf |