FDA — authorised 18 December 1979
- Marketing authorisation holder: BAXTER HLTHCARE
- Status: approved
🇺🇸 Forane in United States
FDA authorised Forane on 18 December 1979
Marketing authorisations
FDA — authorised 18 December 1979
- Application: NDA017624
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: FORANE
- Indication: LIQUID — INHALATION
- Status: approved
FDA — authorised 25 January 1993
- Application: ANDA074097
- Marketing authorisation holder: HOSPIRA
- Local brand name: ISOFLURANE
- Indication: LIQUID — INHALATION
- Status: approved
FDA — authorised 30 September 1994
- Application: ANDA074416
- Marketing authorisation holder: PIRAMAL CRITICAL
- Local brand name: ISOFLURANE
- Indication: LIQUID — INHALATION
- Status: approved
The FDA approved Forane for labeling indications. This approval was granted to PIRAMAL CRITICAL on January 8, 2024, under the standard expedited pathway. The application number for this approval is ANDA074416.
FDA — authorised 12 May 1995
- Application: ANDA074393
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: ISOFLURANE
- Indication: LIQUID — INHALATION
- Status: approved
FDA — authorised 27 June 1995
- Application: ANDA074502
- Marketing authorisation holder: PIRAMAL PHARMA
- Local brand name: ISOFLURANE
- Indication: LIQUID — INHALATION
- Status: approved
FDA — authorised 20 October 1999
- Application: ANDA075225
- Marketing authorisation holder: HALOCARBON PRODS
- Local brand name: ISOFLURANE
- Indication: LIQUID — INHALATION
- Status: approved
FDA — authorised 4 November 2025
- Application: ANDA216527
- Marketing authorisation holder: SHANDONG
- Local brand name: ISOFLURANE
- Indication: LIQUID — INHALATION
- Status: approved
Forane 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 Forane approved in United States?
Yes. FDA authorised it on 18 December 1979; FDA authorised it on 18 December 1979; FDA authorised it on 25 January 1993.
Who is the marketing authorisation holder for Forane in United States?
BAXTER HLTHCARE holds the US marketing authorisation.