FDA — authorised 27 August 2013
- Application: ANDA202289
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Labeling
- Status: approved
🇺🇸 Cozaar in United States
FDA authorised Cozaar on 27 August 2013
Marketing authorisations
FDA — authorised 29 September 2017
- Application: ANDA201845
- Marketing authorisation holder: JUBILANT CADISTA
- Indication: Labeling
- Status: approved
FDA — authorised 24 February 2020
- Application: ANDA091617
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 3 March 2020
- Application: ANDA091629
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 9 October 2025
- Application: ANDA218015
- Marketing authorisation holder: GRANULES
- Indication: Labeling
- Status: approved
The FDA approved Cozaar, manufactured by GRANULES, for its labeling indication on 2025-10-09. This approval was granted under the standard expedited pathway. The application number for this approval is ANDA218015.
Cozaar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Cozaar approved in United States?
Yes. FDA authorised it on 27 August 2013; FDA authorised it on 29 September 2017; FDA authorised it on 24 February 2020.
Who is the marketing authorisation holder for Cozaar in United States?
MACLEODS PHARMS LTD holds the US marketing authorisation.