FDA — authorised 20 February 2008
- Marketing authorisation holder: HISAMITSU PHARM CO
- Status: approved
🇺🇸 Salonpas in United States
FDA authorised Salonpas on 20 February 2008
Marketing authorisations
FDA — authorised 30 March 2015
- Application: NDA022029
- Marketing authorisation holder: HISAMITSU PHARM CO
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 21 November 2024
- Application: ANDA202027
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
The FDA approved Salonpas for labeling indications on November 21, 2024. This approval was granted to APOTEX under the standard expedited pathway. The application number for this approval is ANDA202027.
Salonpas in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Salonpas approved in United States?
Yes. FDA authorised it on 20 February 2008; FDA authorised it on 30 March 2015; FDA authorised it on 21 November 2024.
Who is the marketing authorisation holder for Salonpas in United States?
HISAMITSU PHARM CO holds the US marketing authorisation.