FDA — authorised 21 December 1988
- Application: NDA019488
- Marketing authorisation holder: CHIESI
- Local brand name: CARDENE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Cardene in United States
FDA authorised Cardene on 21 December 1988
Marketing authorisations
FDA — authorised 21 December 1988
- Marketing authorisation holder: CHIESI USA INC
- Status: approved
FDA — authorised 30 January 1992
- Application: NDA019734
- Marketing authorisation holder: CHIESI
- Local brand name: CARDENE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 May 2020
- Application: ANDA090664
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Indication: Labeling
- Status: approved
FDA — authorised 3 May 2023
- Application: ANDA217555
- Marketing authorisation holder: BIONPHARMA
- Status: approved
FDA — authorised 17 July 2023
- Application: ANDA215377
- Marketing authorisation holder: SENORES PHARMS
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA219608
- Marketing authorisation holder: QILU PHARM HAINAN
- Status: approved
FDA — authorised 18 December 2025
- Application: ANDA217548
- Marketing authorisation holder: CHENGDU SHUODE
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved the application (ANDA217548) submitted by CHENGDU SHUODE for Cardene on 18 December 2025. This approval allows CHENGDU SHUODE to manufacture Cardene in the United States. Cardene is a drug used for manufacturing purposes, specifically for the control of manufacturing (CMC).
Cardene 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 Cardene approved in United States?
Yes. FDA authorised it on 21 December 1988; FDA authorised it on 21 December 1988; FDA authorised it on 30 January 1992.
Who is the marketing authorisation holder for Cardene in United States?
CHIESI holds the US marketing authorisation.