Minoxidil (For Men), Minoxidil (For Women)

ANDA 74767, held by Aurobindo Pharma Ltd. Minoxidil.

As of Nov 15, 2026, ANDA 74767 (Minoxidil (For Men), Minoxidil (For Women)), held by Aurobindo Pharma Ltd, was first approved by FDA on Feb 28, 1997, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1997
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Feb 28, 1997	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Nov 25, 1997	Supplement 2Manufacturing	Approved	None posted
Nov 25, 1997	Supplement 1Labeling	Approved	None posted
Feb 28, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74767
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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