FDA — authorised 19 February 1948
- Application: NDA006328
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: ISUPREL
- Indication: TABLET — RECTAL, SUBLINGUAL
- Status: approved
🇺🇸 Isuprel in United States
FDA authorised Isuprel on 19 February 1948
Marketing authorisations
FDA — authorised 9 March 1956
- Status: approved
FDA — authorised 25 May 1956
- Application: NDA010515
- Marketing authorisation holder: BAUSCH
- Local brand name: ISUPREL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA006327
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: ISUPREL
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: NDA011178
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: ISUPREL
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
Isuprel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Isuprel approved in United States?
Yes. FDA authorised it on 19 February 1948; FDA authorised it on 9 March 1956; FDA authorised it on 25 May 1956.
Who is the marketing authorisation holder for Isuprel in United States?
SANOFI AVENTIS US holds the US marketing authorisation.