FDA — authorised 30 January 1992
- Application: NDA019734
- Marketing authorisation holder: CHIESI
- Local brand name: CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 NICARDIPINE HYDROCHLORIDE in United States
FDA authorised NICARDIPINE HYDROCHLORIDE on 30 January 1992
Marketing authorisations
FDA — authorised 21 February 1992
- Application: NDA020005
- Marketing authorisation holder: CHIESI
- Local brand name: CARDENE SR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 July 1996
- Application: ANDA074642
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 October 1996
- Application: ANDA074540
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 October 1996
- Application: ANDA074670
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 March 1998
- Application: ANDA074928
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 July 2008
- Application: NDA022276
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 17 November 2009
- Application: ANDA090534
- Marketing authorisation holder: AM REGENT
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 2009
- Application: ANDA090125
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 May 2020
- Application: ANDA090664
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Indication: Labeling
- Status: approved
FDA — authorised 8 April 2021
- Application: ANDA211121
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 May 2023
- Application: ANDA217555
- Marketing authorisation holder: BIONPHARMA
- Status: approved
FDA — authorised 7 July 2023
- Application: ANDA216420
- Marketing authorisation holder: MICRO LABS
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 July 2023
- Application: ANDA215377
- Marketing authorisation holder: SENORES PHARMS
- Status: approved
FDA — authorised 10 April 2024
- Application: ANDA218202
- Marketing authorisation holder: AMNEAL
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 April 2024
- Application: ANDA203978
- Marketing authorisation holder: INFORLIFE
- Local brand name: NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 24 September 2024
- Application: ANDA215592
- Marketing authorisation holder: CIPLA
- Local brand name: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 25 June 2025
- Application: ANDA218638
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 October 2025
- Application: ANDA220243
- Marketing authorisation holder: CAPLIN
- Local brand name: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- 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
NICARDIPINE HYDROCHLORIDE 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 NICARDIPINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 30 January 1992; FDA authorised it on 21 February 1992; FDA authorised it on 18 July 1996.
Who is the marketing authorisation holder for NICARDIPINE HYDROCHLORIDE in United States?
CHIESI holds the US marketing authorisation.