FDA — authorised 10 December 2008
- Application: ANDA040784
- Marketing authorisation holder: XGEN PHARMS
- Status: approved
🇺🇸 Diamox in United States
FDA authorised Diamox on 10 December 2008
Marketing authorisations
FDA — authorised 9 January 2016
- Application: ANDA040195
- Marketing authorisation holder: TARO
- Indication: Labeling
- Status: approved
FDA — authorised 30 September 2016
- Application: ANDA203434
- Marketing authorisation holder: NOVAST LABS
- Status: approved
FDA — authorised 16 January 2019
- Application: ANDA205301
- Marketing authorisation holder: CADILA
- Status: approved
FDA — authorised 12 March 2025
- Application: ANDA211151
- Marketing authorisation holder: AJANTA PHARMA LTD
- Indication: Labeling
- Status: approved
The FDA approved Diamox for its labelled indication on 12 March 2025. The marketing authorisation holder is AJANTA PHARMA LTD. The approval was granted under the standard expedited pathway.
Diamox in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Diamox approved in United States?
Yes. FDA authorised it on 10 December 2008; FDA authorised it on 9 January 2016; FDA authorised it on 30 September 2016.
Who is the marketing authorisation holder for Diamox in United States?
XGEN PHARMS holds the US marketing authorisation.