FDA — authorised 17 December 1996
- Application: NDA020511
- Marketing authorisation holder: ULURU
- Local brand name: APHTHASOL
- Indication: PASTE — DENTAL
- Status: approved
🇺🇸 Amoxanox in United States
FDA authorised Amoxanox on 17 December 1996
Marketing authorisations
FDA — authorised 29 September 2004
- Application: NDA021727
- Marketing authorisation holder: ULURU
- Local brand name: AMLEXANOX
- Indication: PATCH — TOPICAL
- Status: approved
FDA
- Status: approved
Amoxanox 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 Amoxanox approved in United States?
Yes. FDA authorised it on 17 December 1996; FDA authorised it on 29 September 2004; FDA has authorised it.
Who is the marketing authorisation holder for Amoxanox in United States?
ULURU holds the US marketing authorisation.