FDA — authorised 28 December 1984
- Application: NDA018770
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: TORNALATE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA authorised Tornalate on 28 December 1984
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 28 December 1984; FDA authorised it on 19 February 1992; FDA has authorised it.
SANOFI AVENTIS US holds the US marketing authorisation.