Mustargen

NDA 6695, held by Recordati Rare. Mechlorethamine Hydrochloride.

As of Nov 13, 2026, NDA 6695 (Mustargen), held by Recordati Rare, was first approved by FDA on Mar 15, 1949, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 15, 1949
Review: Priority
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Mar 15, 1949	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mustargen10MG/VIAL · injectable;injection	Mechlorethamine Hydrochloride	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Feb 9, 2004	Supplement 31Labeling · Standard review	Approved	Label Letter
Mar 19, 2003	Supplement 30Labeling · Standard review	Approved	Letter
Nov 17, 2000	Supplement 29Manufacturing · Priority review	Approved	None posted
Mar 15, 2000	Supplement 28Labeling · Standard review	Approved	None posted
Oct 16, 1998	Supplement 27Manufacturing · Priority review	Approved	None posted
Oct 16, 1998	Supplement 26Manufacturing · Priority review	Approved	None posted
Dec 13, 1995	Supplement 25Manufacturing · Priority review	Approved	None posted
Apr 10, 1995	Supplement 24Manufacturing · Priority review	Approved	None posted
Mar 22, 1995	Supplement 23Manufacturing · Priority review	Approved	None posted
Jan 12, 1995	Supplement 21Manufacturing · Priority review	Approved	None posted
Oct 20, 1994	Supplement 22Manufacturing · Priority review	Approved	None posted
Sep 18, 1987	Supplement 20Labeling	Approved	None posted
Jan 15, 1987	Supplement 19Labeling	Approved	None posted
Mar 29, 1986	Supplement 17Labeling	Approved	None posted
Feb 21, 1983	Supplement 16Manufacturing · Priority review	Approved	None posted
Mar 4, 1982	Supplement 15Manufacturing · Priority review	Approved	None posted
Feb 19, 1980	Supplement 14Labeling	Approved	None posted
Jun 12, 1978	Supplement 13Labeling	Approved	None posted
Mar 15, 1949	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 6695
Drugs@FDA: Overview at FDA
Company: Recordati Rare Diseases

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