Minoxidil

ANDA 91344, held by Perrigo Pharma Intl. Minoxidil.

As of Nov 15, 2026, ANDA 91344 (Minoxidil), held by Perrigo Pharma Intl, was first approved by FDA on Apr 28, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 28, 2011
Supplements approved: 3
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 (vertex only, 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 4 submissions below

Date	Submission	Status	Documents
Apr 28, 2011	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Minoxidil5% · aerosol, foam;topical	Minoxidil	OTC

All 4 submissions, including labeling and manufacturing supplements


Jun 10, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Mar 3, 2017	Supplement 16Labeling · Standard review	Approved	None posted
Nov 13, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Apr 28, 2011	Original application	Approved	Letter

Identifiers

Application: ANDA 91344
Drugs@FDA: Overview at FDA
Company: Perrigo Pharma International

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