Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 75331, held by Sun Pharma Canada. Diflorasone Diacetate.
As of Nov 15, 2026, ANDA 75331 (Diflorasone Diacetate), held by Sun Pharma Canada, was first approved by FDA on May 14, 1999, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 14, 1999 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diflorasone Diacetate0.05% · ointment;topical | Diflorasone Diacetate | Rx |
| Jan 8, 2003 | Supplement 4Manufacturing | Approved | None posted |
| Dec 29, 2000 | Supplement 2Manufacturing | Approved | None posted |
| Nov 1, 1999 | Supplement 1Manufacturing | Approved | None posted |
| May 14, 1999 | Original application | Approved | None posted |
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
