Minoxidil (For Men)

ANDA 74500, held by Copley Pharm. Minoxidil.

As of Nov 15, 2026, ANDA 74500 (Minoxidil (For Men)), held by Copley Pharm, was first approved by FDA on May 23, 1996, with 5 approved supplements and 0 published complete response letters.

First approved: May 23, 1996
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 23, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Minoxidil (For Men)2% · solution;topical	Minoxidil	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Mar 23, 1999	Supplement 5Manufacturing	Approved	None posted
Feb 6, 1998	Supplement 4Manufacturing	Approved	None posted
Oct 30, 1997	Supplement 1Manufacturing	Approved	None posted
Oct 30, 1997	Supplement 2Labeling	Approved	None posted
May 13, 1997	Supplement 3Manufacturing	Approved	None posted
May 23, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74500
Drugs@FDA: Overview at FDA
Company: Copley Pharmaceutical

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