FDA — authorised 24 February 1959
- Application: NDA011835
- Marketing authorisation holder: MERCK
- Local brand name: HYDRODIURIL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Microzide in United States
FDA authorised Microzide on 24 February 1959
Marketing authorisations
FDA — authorised 27 December 1996
- Application: NDA020504
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: MICROZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 March 2005
- Application: NDA020758
- Marketing authorisation holder: SANOFI AVENTIS US
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 September 2012
- Application: NDA200175
- Marketing authorisation holder: COSETTE
- Indication: Labeling
- Status: approved
FDA — authorised 30 June 2015
- Application: ANDA076631
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 23 June 2016
- Application: ANDA204100
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 29 September 2017
- Application: ANDA201845
- Marketing authorisation holder: JUBILANT CADISTA
- Indication: Labeling
- Status: approved
Microzide 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 Microzide approved in United States?
Yes. FDA authorised it on 24 February 1959; FDA authorised it on 27 December 1996; FDA authorised it on 15 March 2005.
Who is the marketing authorisation holder for Microzide in United States?
MERCK holds the US marketing authorisation.