FDA — authorised 27 July 1953
- Application: NDA008943
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: DIAMOX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Normal Dose Acetazolamide in United States
FDA authorised Normal Dose Acetazolamide on 27 July 1953
Marketing authorisations
FDA — authorised 25 June 1954
- Application: NDA009388
- Marketing authorisation holder: TEVA WOMENS
- Local brand name: DIAMOX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 January 1962
- Application: NDA012945
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: DIAMOX
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Normal Dose Acetazolamide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Normal Dose Acetazolamide approved in United States?
Yes. FDA authorised it on 27 July 1953; FDA authorised it on 25 June 1954; FDA authorised it on 25 January 1962.
Who is the marketing authorisation holder for Normal Dose Acetazolamide in United States?
TEVA BRANDED PHARM holds the US marketing authorisation.