FDA — authorised 20 November 2018
- Application: ANDA200480
- Marketing authorisation holder: SEPTODONT
- Indication: Not Applicable
- Status: approved
🇺🇸 Dyclone in United States
FDA authorised Dyclone on 20 November 2018
Marketing authorisations
FDA
- Status: approved
FDA
- Application: NDA009925
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: DYCLONE
- Indication: SOLUTION — TOPICAL
- Status: approved
Dyclone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Dyclone approved in United States?
Yes. FDA authorised it on 20 November 2018; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Dyclone in United States?
SEPTODONT holds the US marketing authorisation.