Treats multiple myeloma (MM). NDA 211379, held by Dexcel. Dexamethasone.
As of Nov 13, 2026, NDA 211379 (Hemady), held by Dexcel, was first approved by FDA on Oct 3, 2019, with 2 approved supplements and 0 published complete response letters.
HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 3, 2019 | Original applicationTYPE 4/5 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hemady20MG · tablet;oral | Dexamethasone | RxReference drug |
| Jun 5, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Jun 24, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Oct 3, 2019 | Original applicationTYPE 4/5 · Standard review | 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
