🇺🇸 Minoxidil Topical in United States

FDA authorised Minoxidil Topical on 30 July 1999 · 43 US adverse-event reports

Marketing authorisations

FDA — authorised 30 July 1999

  • Application: ANDA075357
  • Marketing authorisation holder: L PERRIGO CO
  • Status: approved

FDA — authorised 24 August 2004

  • Application: ANDA076239
  • Marketing authorisation holder: PURE SOURCE
  • Status: supplemented

FDA — authorised 9 November 2007

  • Application: ANDA078176
  • Marketing authorisation holder: PURE SOURCE
  • Status: approved

FDA — authorised 28 April 2011

  • Application: ANDA091344
  • Marketing authorisation holder: PERRIGO PHARMA INTL
  • Status: approved

FDA — authorised 26 November 2024

  • Application: ANDA218175
  • Marketing authorisation holder: TARO
  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Alopecia — 8 reports (18.6%)
  2. Drug Ineffective — 6 reports (13.95%)
  3. Product Use Issue — 5 reports (11.63%)
  4. Pruritus — 5 reports (11.63%)
  5. Dizziness — 4 reports (9.3%)
  6. Condition Aggravated — 3 reports (6.98%)
  7. Headache — 3 reports (6.98%)
  8. Off Label Use — 3 reports (6.98%)
  9. Pain — 3 reports (6.98%)
  10. Skin Irritation — 3 reports (6.98%)

Source database →

Other Dermatology approved in United States

Frequently asked questions

Is Minoxidil Topical approved in United States?

Yes. FDA authorised it on 30 July 1999; FDA authorised it on 24 August 2004; FDA authorised it on 9 November 2007.

Who is the marketing authorisation holder for Minoxidil Topical in United States?

L PERRIGO CO holds the US marketing authorisation.