Treats atopic dermatitis. ANDA 202368, held by Sun Pharma Canada. Fluocinolone Acetonide.
As of Nov 15, 2026, ANDA 202368 (Fluocinolone Acetonide), held by Sun Pharma Canada, was first approved by FDA on May 19, 2016, with 0 approved supplements and 0 published complete response letters.
Fluocinolone acetonide topical oil is a corticosteroid indicated for the topical treatment of atopic dermatitis in adult patients topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks Limitations of Use: Apply the least amount to cover affected areas. Discontinue when disease is controlled. Do not use in the diaper area. Do not use on the face, axillae, or groin. ( 1.3, 6.2, 8.4 ) 1.1 Adult Patients with Atopic Dermatitis
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluocinolone Acetonide0.01% · oil;topical | Fluocinolone Acetonide | Rx |
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
