Mitoxantrone Hydrochloride

ANDA 78980, held by Rising. Mitoxantrone Hydrochloride.

As of Nov 15, 2026, ANDA 78980 (Mitoxantrone Hydrochloride), held by Rising, was first approved by FDA on Apr 13, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 13, 2009
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 13, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Mitoxantrone HydrochlorideEQ 20MG BASE/10ML (EQ 2MG BASE/ML) · injectable;injection	Mitoxantrone Hydrochloride	Discontinued
Mitoxantrone HydrochlorideEQ 30MG BASE/15ML (EQ 2MG BASE/ML) · injectable;injection	Mitoxantrone Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 20, 2009	Supplement 2Labeling	Approved	None posted
Apr 13, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78980
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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