Treats Duchenne muscular dystrophy (DMD). ANDA 220042, held by Zydus Lifesciences. Deflazacort.
As of Nov 14, 2026, ANDA 220042 (Deflazacort), held by Zydus Lifesciences, was first approved by FDA on Oct 3, 2025, 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 |
|---|---|---|---|
| Oct 3, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Deflazacort22.75MG/ML · suspension;oral | Deflazacort | Rx |
| Jan 13, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 3, 2025 | 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
