Minoxidil (For Men)

ANDA 74643, held by Bausch And Lomb. Minoxidil.

As of Nov 15, 2026, ANDA 74643 (Minoxidil (For Men)), held by Bausch And Lomb, was first approved by FDA on Apr 9, 1996, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 9, 1996
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 9, 1996	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Aug 11, 1999	Supplement 10Manufacturing	Approved	None posted
Aug 11, 1999	Supplement 11Manufacturing	Approved	None posted
Aug 11, 1999	Supplement 12Manufacturing	Approved	None posted
Apr 29, 1999	Supplement 9Manufacturing	Approved	None posted
Mar 27, 1998	Supplement 8Manufacturing	Approved	None posted
Apr 7, 1997	Supplement 4Manufacturing	Approved	None posted
Oct 18, 1996	Supplement 1Labeling	Approved	None posted
Oct 18, 1996	Supplement 2Manufacturing	Approved	None posted
Apr 9, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74643
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

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