FDA — authorised 23 February 1982
- Application: NDA018185
- Marketing authorisation holder: ZYLA
- Local brand name: INDOCIN SR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Ketotifen/Indomethacin in United States
FDA authorised Ketotifen/Indomethacin on 23 February 1982
Marketing authorisations
FDA — authorised 24 February 2014
- Application: NDA204768
- Marketing authorisation holder: GENUS
- Local brand name: TIVORBEX
- Indication: CAPSULE — ORAL
- Status: approved
Frequently asked questions
Is Ketotifen/Indomethacin approved in United States?
Yes. FDA authorised it on 23 February 1982; FDA authorised it on 24 February 2014.
Who is the marketing authorisation holder for Ketotifen/Indomethacin in United States?
ZYLA holds the US marketing authorisation.