FDA — authorised 18 May 2007
- Application: ANDA077179
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Caduet in United States
FDA authorised Caduet on 18 May 2007
Marketing authorisations
FDA — authorised 27 June 2007
- Application: ANDA077080
- Marketing authorisation holder: SYNTHON PHARMS
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2007
- Application: ANDA076846
- Marketing authorisation holder: TEVA
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2007
- Application: ANDA078226
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2007
- Application: ANDA077759
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2007
- Application: ANDA077974
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 2007
- Application: ANDA078043
- Marketing authorisation holder: LUPIN
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 2007
- Application: ANDA078021
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2007
- Application: ANDA077671
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2007
- Application: ANDA077955
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 2007
- Application: ANDA076859
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2007
- Application: ANDA077073
- Marketing authorisation holder: CIPLA
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 2007
- Application: ANDA078231
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2008
- Application: ANDA078081
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2008
- Application: ANDA078224
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 September 2008
- Application: ANDA078573
- Marketing authorisation holder: TORRENT PHARMS
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2009
- Application: ANDA078552
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 May 2009
- Application: ANDA078925
- Marketing authorisation holder: ALKEM
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 May 2010
- Application: ANDA077375
- Marketing authorisation holder: RISING
- Local brand name: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 July 2010
- Application: NDA200175
- Marketing authorisation holder: COSETTE
- Local brand name: TRIBENZOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2010
- Application: ANDA078381
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 April 2011
- Application: ANDA077771
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 2011
- Application: ANDA090752
- Marketing authorisation holder: CHINA RESOURCES
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2012
- Application: ANDA202239
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 April 2013
- Application: ANDA202553
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 October 2013
- Application: ANDA203245
- Marketing authorisation holder: UNICHEM
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 2013
- Application: ANDA091431
- Marketing authorisation holder: HERITAGE
- Local brand name: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 March 2015
- Application: ANDA090483
- Marketing authorisation holder: MYLAN
- Local brand name: AMLODIPINE BESYLATE AND VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2015
- Application: ANDA202829
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: AMLODIPINE BESYLATE AND VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2015
- Application: ANDA091235
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: AMLODIPINE BESYLATE AND VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2015
- Application: ANDA090245
- Marketing authorisation holder: LUPIN
- Local brand name: AMLODIPINE BESYLATE AND VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2015
- Application: ANDA201593
- Marketing authorisation holder: TORRENT
- Local brand name: AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 2015
- Application: ANDA206367
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 2016
- Application: ANDA207821
- Marketing authorisation holder: PURACAP LABS BLU
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 2016
- Application: ANDA205137
- Marketing authorisation holder: HETERO LABS
- Local brand name: AMLODIPINE BESYLATE AND VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2016
- Application: ANDA207216
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 2016
- Application: ANDA202933
- Marketing authorisation holder: TORRENT
- Local brand name: AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 2017
- Application: ANDA207450
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 July 2017
- Application: ANDA207807
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 2017
- Application: ANDA207073
- Marketing authorisation holder: ALEMBIC
- Local brand name: AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 August 2017
- Application: ANDA209042
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 November 2017
- Application: ANDA207435
- Marketing authorisation holder: MICRO LABS
- Local brand name: AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2018
- Application: NDA210045
- Marketing authorisation holder: PURPLE BIOTECH
- Local brand name: CONSENSI
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 December 2018
- Application: ANDA209010
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 November 2019
- Application: ANDA205199
- Marketing authorisation holder: APOTEX
- Local brand name: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2022
- Application: NDA214439
- Marketing authorisation holder: CMP DEV LLC
- Local brand name: NORLIQVA
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 22 May 2025
- Application: ANDA217279
- Marketing authorisation holder: ALEMBIC
- Local brand name: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 2025
- Application: NDA219423
- Marketing authorisation holder: AZURITY
- Local brand name: WIDAPLIK
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 2025
- Application: NDA219531
- Marketing authorisation holder: BRILLIAN PHARMA
- Local brand name: SDAMLO
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA077333
- Marketing authorisation holder: GEDEON RICHTER USA
- Local brand name: AMLODIPINE BESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Caduet 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 Caduet approved in United States?
Yes. FDA authorised it on 18 May 2007; FDA authorised it on 27 June 2007; FDA authorised it on 28 June 2007.
Who is the marketing authorisation holder for Caduet in United States?
TEVA PHARMS holds the US marketing authorisation.