Alkeran

NDA 20207, held by Apotex. Melphalan Hydrochloride.

As of Nov 13, 2026, NDA 20207 (Alkeran), held by Apotex, was first approved by FDA on Nov 18, 1992, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 18, 1992
Review: Priority
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Nov 18, 1992	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
AlkeranEQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Melphalan Hydrochloride	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 9, 2011	Supplement 16Labeling · Standard review	Approved	Letter Label
May 2, 2011	Supplement 17Labeling · Standard review	Approved	Letter Label
Jun 14, 2005	Supplement 12Labeling · Standard review	Approved	Letter
Apr 29, 2003	Supplement 7Labeling · Standard review	Approved	Label Letter
Jan 7, 2002	Supplement 5Labeling · Standard review	Approved	Letter
Oct 9, 2001	Supplement 4Manufacturing · Priority review	Approved	None posted
Oct 9, 2001	Supplement 3Manufacturing · Priority review	Approved	None posted
Mar 3, 2000	Supplement 2Manufacturing · Priority review	Approved	None posted
Jan 5, 1994	Supplement 1Labeling · Standard review	Approved	None posted
Nov 18, 1992	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20207
Drugs@FDA: Overview at FDA
Company: Apotex

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