Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022259
Company: HILL DERMACEUTICALS
Company: HILL DERMACEUTICALS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLAK | FLUOROURACIL | 4% | CREAM;TOPICAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/25/2022 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022259Orig1s008lbl.pdf | |
| 08/25/2022 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022259Orig1s008lbl.pdf | |
| 09/18/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022259s000lbl.pdf |