Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021112
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRI-LUMA | FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN | 0.01%;4%;0.05% | CREAM;TOPICAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/31/2014 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021112s009lbl.pdf | |
| 01/16/2013 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021112s006lbl.pdf | |
| 01/18/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21112lbl.pdf |