Treats moderate to severe melasma of the face, in the presence of measures for sun…. NDA 21112, held by Galderma Labs LP. Fluocinolone Acetonide; Hydroquinone; Tretinoin.
As of Nov 15, 2026, NDA 21112 (Tri-Luma), held by Galderma Labs LP, was first approved by FDA on Jan 18, 2002, with 6 approved supplements and 0 published complete response letters.
TRI-LUMA Cream is a combination of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. 1.1 Indication
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 2002 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tri-Luma0.01%;4%;0.05% · cream;topical | Fluocinolone Acetonide; Hydroquinone; Tretinoin | RxReference drug |
| Jan 20, 2015 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 10, 2014 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 31, 2014 | Supplement 9Labeling · Standard review | Approved | |
| Oct 18, 2013 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 12, 2013 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 16, 2013 | Supplement 6Labeling | Approved | |
| Jan 18, 2002 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
