Minoxidil (For Men), Minoxidil (For Women)

ANDA 74924, held by Apotex Inc. Minoxidil.

As of Nov 15, 2026, ANDA 74924 (Minoxidil (For Men), Minoxidil (For Women)), held by Apotex Inc, was first approved by FDA on Apr 29, 1998, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 29, 1998
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
Apr 29, 1998	Original application	Approved	Letter

Products

2 strengths and forms


Minoxidil (For Men)2% · solution;topical	Minoxidil	Discontinued
Minoxidil (For Women)2% · solution;topical	Minoxidil	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Mar 15, 2007	Supplement 19Labeling	Approved	None posted
Jun 7, 2006	Supplement 17Labeling	Approved	None posted
May 5, 2005	Supplement 14Labeling	Approved	None posted
Mar 18, 2004	Supplement 12Labeling	Approved	None posted
Aug 22, 2002	Supplement 7Manufacturing	Approved	None posted
Aug 22, 2002	Supplement 8Labeling	Approved	None posted
Oct 15, 2001	Supplement 6Manufacturing	Approved	None posted
Jan 19, 2001	Supplement 5Manufacturing	Approved	None posted
Jun 17, 1999	Supplement 2Manufacturing	Approved	None posted
Apr 29, 1998	Original application	Approved	Letter

Identifiers

Application: ANDA 74924
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