Treats Duchenne muscular dystrophy (DMD). ANDA 217123, held by Aurobindo Pharma Ltd. Deflazacort.
As of Nov 14, 2026, ANDA 217123 (Deflazacort), held by Aurobindo Pharma Ltd, was first approved by FDA on Feb 9, 2024, with 1 approved supplement and 0 published complete response letters.
Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 2024 | Original application | Approved |
| Deflazacort6MG · tablet;oral | Deflazacort | Rx |
| Deflazacort18MG · tablet;oral | Deflazacort | Rx |
| Deflazacort30MG · tablet;oral | Deflazacort | Rx |
| Deflazacort36MG · tablet;oral | Deflazacort | Rx |
| Nov 8, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 9, 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
