FDA — authorised 5 September 2000
- Application: NDA021093
- Marketing authorisation holder: ANI PHARMS
- Status: supplemented
🇺🇸 Candesartan cilexetil and hydrochlorothiazide in United States
FDA authorised Candesartan cilexetil and hydrochlorothiazide on 5 September 2000
Marketing authorisations
FDA — authorised 4 December 2012
- Application: ANDA202884
- Marketing authorisation holder: APOTEX INC
- Local brand name: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 2012
- Application: ANDA090704
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2013
- Application: ANDA202965
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2015
- Application: ANDA204100
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2017
- Application: ANDA203466
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 April 2018
- Application: ANDA207455
- Marketing authorisation holder: PRINSTON INC
- Local brand name: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Candesartan cilexetil and hydrochlorothiazide 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 Candesartan cilexetil and hydrochlorothiazide approved in United States?
Yes. FDA authorised it on 5 September 2000; FDA authorised it on 4 December 2012; FDA authorised it on 4 December 2012.
Who is the marketing authorisation holder for Candesartan cilexetil and hydrochlorothiazide in United States?
ANI PHARMS holds the US marketing authorisation.