FDA — authorised 14 May 2010
- Application: NDA022382
- Marketing authorisation holder: ZYLA
- Local brand name: SPRIX
- Indication: SPRAY, METERED — NASAL
- Status: approved
🇺🇸 Intranasal Ketoralac in United States
FDA authorised Intranasal Ketoralac on 14 May 2010
Marketing authorisations
FDA
- Status: approved
Intranasal Ketoralac 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 Intranasal Ketoralac approved in United States?
Yes. FDA authorised it on 14 May 2010; FDA has authorised it.
Who is the marketing authorisation holder for Intranasal Ketoralac in United States?
ZYLA holds the US marketing authorisation.