Treats Duchenne muscular dystrophy (DMD). ANDA 219930, held by Sun Pharm Inds Inc. Deflazacort.
As of Nov 14, 2026, ANDA 219930 (Deflazacort), held by Sun Pharm Inds Inc, was first approved by FDA on Jan 27, 2026, with 0 approved supplements 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 |
|---|---|---|---|
| Jan 27, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Deflazacort22.75MG/ML · suspension;oral | Deflazacort | 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
