Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 015296
Company: EUROFARMA
Company: EUROFARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYNALAR | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | AT | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/19/2012 | SUPPL-64 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/015296s064lbl.pdf |