FDA — authorised 24 August 2004
- Application: ANDA076239
- Marketing authorisation holder: PURE SOURCE
- Local brand name: THEROXIDIL
- Indication: SOLUTION — TOPICAL
- Status: approved
🇺🇸 5% Minoxidil in United States
FDA authorised 5% Minoxidil on 24 August 2004
Marketing authorisations
FDA — authorised 14 July 2005
- Application: ANDA075357
- Marketing authorisation holder: L PERRIGO CO
- Indication: Labeling
- Status: approved
5% Minoxidil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is 5% Minoxidil approved in United States?
Yes. FDA authorised it on 24 August 2004; FDA authorised it on 14 July 2005.
Who is the marketing authorisation holder for 5% Minoxidil in United States?
PURE SOURCE holds the US marketing authorisation.