FDA — authorised 30 May 1986
- Application: NDA018471
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: OCUCLEAR
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Afrin in United States
FDA authorised Afrin on 30 May 1986
Marketing authorisations
FDA — authorised 31 March 1989
- Application: NDA019407
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: VISINE L.R.
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 29 June 2016
- Application: NDA208032
- Marketing authorisation holder: ST RENATUS
- Local brand name: KOVANAZE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 4 October 2021
- Application: ANDA213584
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: OXYMETAZOLINE HYDROCHLORIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Afrin approved in United States?
Yes. FDA authorised it on 30 May 1986; FDA authorised it on 31 March 1989; FDA authorised it on 29 June 2016.
Who is the marketing authorisation holder for Afrin in United States?
BAYER HEALTHCARE LLC holds the US marketing authorisation.