Minoxidil (For Men), Minoxidil (For Women)

ANDA 209074, held by Taro. Minoxidil.

As of Nov 15, 2026, ANDA 209074 (Minoxidil (For Men), Minoxidil (For Women)), held by Taro, was first approved by FDA on Apr 22, 2019, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 22, 2019
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use to regrow hair on the top of the scalp (see pictures on side of this carton)

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Apr 22, 2019	Original application	Approved	Letter
Dec 31, 2018	Original application	Approved	Letter

Products

2 strengths and forms


Minoxidil (For Men)5% · aerosol, foam;topical	Minoxidil	OTC
Minoxidil (For Women)5% · aerosol, foam;topical	Minoxidil	OTC

All 6 submissions, including labeling and manufacturing supplements


Sep 4, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Sep 4, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Dec 4, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Dec 4, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Apr 22, 2019	Original application	Approved	Letter
Dec 31, 2018	Original application	Approved	Letter

Identifiers

Application: ANDA 209074
Drugs@FDA: Overview at FDA
Company: Taro Pharmaceuticals

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