FDA — authorised 6 October 2010
- Application: ANDA091590
- Marketing authorisation holder: MYLAN
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cozaar in United States
FDA authorised Cozaar on 6 October 2010
Marketing authorisations
FDA — authorised 6 October 2010
- Application: ANDA090790
- Marketing authorisation holder: APOTEX CORP
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2010
- Application: ANDA090467
- Marketing authorisation holder: TORRENT PHARMS
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2010
- Application: ANDA090083
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2010
- Application: ANDA090428
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2010
- Application: ANDA078232
- Marketing authorisation holder: LUPIN LTD
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2010
- Application: ANDA078243
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2010
- Application: ANDA091129
- Marketing authorisation holder: WATSON LABS
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2010
- Application: ANDA077424
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2010
- Application: ANDA090544
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2010
- Application: ANDA077459
- Marketing authorisation holder: HIKMA
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 June 2011
- Application: ANDA091497
- Marketing authorisation holder: PRINSTON INC
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2012
- Application: ANDA202230
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2012
- Application: ANDA091541
- Marketing authorisation holder: MICRO LABS
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 August 2013
- Application: ANDA202289
- 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
FDA — authorised 4 April 2019
- Application: ANDA204795
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- 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 14 August 2023
- Application: ANDA217396
- Marketing authorisation holder: MSN
- Local brand name: LOSARTAN POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 March 2025
- Application: NDA218772
- Marketing authorisation holder: SCIENTURE
- Local brand name: ARBLI
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 October 2025
- Application: ANDA218015
- Marketing authorisation holder: GRANULES
- Indication: Labeling
- Status: approved
The FDA approved Cozaar, manufactured by GRANULES, on 2025-10-09. This approval was granted under the standard expedited pathway. The approved indication for Cozaar is listed in the labeling.
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 6 October 2010; FDA authorised it on 6 October 2010; FDA authorised it on 6 October 2010.
Who is the marketing authorisation holder for Cozaar in United States?
MYLAN holds the US marketing authorisation.