Treats Duchenne muscular dystrophy (DMD). ANDA 217813, held by Tris Pharma Inc. Deflazacort.
As of Nov 14, 2026, ANDA 217813 (Deflazacort), held by Tris Pharma Inc, was first approved by FDA on Apr 25, 2024, with 1 approved supplement and 0 published complete response letters.
Deflazacort oral suspension is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 25, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Deflazacort22.75MG/ML · suspension;oral | Deflazacort | Rx |
| Oct 29, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 25, 2024 | 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
