NDA 21120, held by Serono Inc. Mitoxantrone Hydrochloride.
As of Nov 13, 2026, NDA 21120 (Novantrone), held by Serono Inc, was first approved by FDA on Oct 13, 2000, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 2000 | Original applicationTYPE 6 · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| NovantroneEQ 2MG BASE/ML · injectable; injection | Mitoxantrone Hydrochloride | Discontinued |
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
