NDA 221093, held by Avyxa Holdings. Doxorubicin Hydrochloride.
As of Nov 13, 2026, NDA 221093 (Oxderys), held by Avyxa Holdings, was first approved by FDA on Nov 9, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Oxderys40MG/20ML (2MG/ML) · vial; multidose | Doxorubicin Hydrochloride | Rx |
| Oxderys160MG/80ML (2MG/ML) · vial; multidose | Doxorubicin Hydrochloride | 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
