FDA — authorised 5 September 2000
- Application: NDA021093
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ATACAND HCT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Candesartan Cilexetil in United States
FDA authorised Candesartan Cilexetil on 5 September 2000
Marketing authorisations
FDA — authorised 3 May 2013
- Application: ANDA078702
- Marketing authorisation holder: MYLAN
- Local brand name: CANDESARTAN CILEXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 December 2016
- Application: ANDA203813
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CANDESARTAN CILEXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 June 2017
- Application: ANDA209119
- Marketing authorisation holder: ALEMBIC
- Local brand name: CANDESARTAN CILEXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 2018
- Application: ANDA210302
- Marketing authorisation holder: ALEMBIC
- Local brand name: CANDESARTAN CILEXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 August 2023
- Application: ANDA206233
- Marketing authorisation holder: PRINSTON INC
- Local brand name: CANDESARTAN CILEXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Marketing authorisation holder: ALEMBIC
- Status: approved
Candesartan Cilexetil 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 Candesartan Cilexetil approved in United States?
Yes. FDA authorised it on 5 September 2000; FDA authorised it on 3 May 2013; FDA authorised it on 5 December 2016.
Who is the marketing authorisation holder for Candesartan Cilexetil in United States?
ANI PHARMS holds the US marketing authorisation.