Daunoxome

NDA 50704, held by Galen (Uk). Daunorubicin Citrate.

As of Nov 13, 2026, NDA 50704 (Daunoxome), held by Galen (Uk), was first approved by FDA on Apr 8, 1996, with 12 approved supplements and 0 published complete response letters.

First approved: Apr 8, 1996
Review: Priority
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Apr 8, 1996	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
DaunoxomeEQ 2MG BASE/ML · injectable, liposomal;injection	Daunorubicin Citrate	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 21, 2002	Supplement 8Labeling · Standard review	Approved	Letter
Feb 10, 2002	Supplement 12Manufacturing	Approved	None posted
May 23, 2000	Supplement 11Manufacturing	Approved	None posted
Mar 28, 2000	Supplement 9Manufacturing	Approved	None posted
Oct 28, 1999	Supplement 10Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 7Manufacturing	Approved	None posted
Feb 26, 1998	Supplement 5Manufacturing	Approved	None posted
Feb 26, 1998	Supplement 6Manufacturing	Approved	None posted
Mar 11, 1997	Supplement 3Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 4Manufacturing	Approved	None posted
Oct 11, 1996	Supplement 2Manufacturing	Approved	None posted
Aug 27, 1996	Supplement 1Manufacturing	Approved	None posted
Apr 8, 1996	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 50704
Drugs@FDA: Overview at FDA
Company: Galen (UK)

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