FDA — authorised 30 January 1974
- Application: NDA017063
- Marketing authorisation holder: ALCON
- Local brand name: ISMOTIC
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Isobide in United States
FDA authorised Isobide on 30 January 1974
Marketing authorisations
FDA — authorised 30 January 1974
- Marketing authorisation holder: ALCON
- Status: approved
FDA — authorised 23 September 1999
- Application: ANDA075147
- Marketing authorisation holder: ANI PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA200270
- Marketing authorisation holder: TORRENT PHARMS
- Status: approved
FDA — authorised 12 March 2019
- Application: NDA020727
- Marketing authorisation holder: AZURITY
- Indication: Labeling
- Status: approved
FDA — authorised 29 April 2022
- Application: ANDA214115
- Marketing authorisation holder: SHANDONG
- Status: approved
FDA — authorised 14 July 2025
- Application: ANDA210822
- Marketing authorisation holder: DEXCEL LTD
- Indication: Labeling
- Status: approved
The FDA approved Isobide for its approved labeling on July 14, 2025. The marketing authorization was granted to DEXCEL LTD under application number ANDA210822. This approval was made through the standard expedited pathway.
Isobide 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 Isobide approved in United States?
Yes. FDA authorised it on 30 January 1974; FDA authorised it on 30 January 1974; FDA authorised it on 23 September 1999.
Who is the marketing authorisation holder for Isobide in United States?
ALCON holds the US marketing authorisation.