Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 75508, held by Sun Pharma Canada. Diflorasone Diacetate.
As of Nov 15, 2026, ANDA 75508 (Diflorasone Diacetate), held by Sun Pharma Canada, was first approved by FDA on Apr 24, 2000, with 4 approved supplements and 0 published complete response letters.
INDICATION AND USAGE Diflorasone diacetate cream USP, 0.05% is a high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diflorasone Diacetate0.05% · cream;topical | Diflorasone Diacetate | Rx |
| Jul 28, 2016 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 28, 2016 | Supplement 14Labeling · Standard review | Approved | None posted |
| Oct 15, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Dec 29, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Apr 24, 2000 | Original application | 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
