FDA — authorised 31 December 1981
- Marketing authorisation holder: PFIZER
- Status: approved
🇺🇸 Procardia in United States
FDA authorised Procardia on 31 December 1981
Marketing authorisations
FDA — authorised 28 April 1989
- Application: ANDA072556
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: NIFEDIPINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 April 1989
- Application: ANDA072579
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: NIFEDIPINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 June 1991
- Application: ANDA073421
- Marketing authorisation holder: CHASE LABS NJ
- Local brand name: NIFEDIPINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 February 1992
- Application: ANDA072651
- Marketing authorisation holder: TEVA
- Local brand name: NIFEDIPINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 April 1993
- Application: NDA020198
- Marketing authorisation holder: NORWICH
- Local brand name: ADALAT CC
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 July 1993
- Application: ANDA072781
- Marketing authorisation holder: ACELLA
- Local brand name: NIFEDIPINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 July 1996
- Application: ANDA073250
- Marketing authorisation holder: VELZEN PHARMA PVT
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 27 September 2000
- Application: ANDA075289
- Marketing authorisation holder: VALEANT PHARMS NORTH
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 December 2000
- Application: ANDA075269
- Marketing authorisation holder: VALEANT PHARMS NORTH
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 August 2002
- Application: ANDA076070
- Marketing authorisation holder: VALEANT PHARMS NORTH
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 November 2005
- Application: ANDA077127
- Marketing authorisation holder: OSMOTICA PHARM US
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 September 2010
- Application: ANDA090602
- Marketing authorisation holder: RISING
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 December 2010
- Application: ANDA201071
- Marketing authorisation holder: RISING
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 April 2013
- Application: ANDA202644
- Marketing authorisation holder: HERITAGE PHARMA
- Status: approved
FDA — authorised 25 August 2016
- Application: ANDA202987
- Marketing authorisation holder: NOVAST LABS
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 December 2017
- Application: ANDA210012
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 March 2019
- Application: ANDA210614
- Marketing authorisation holder: NOVAST LABS
- Status: approved
FDA — authorised 18 November 2020
- Application: ANDA212016
- Marketing authorisation holder: ELITE PHARM SOLUTION
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 July 2021
- Application: ANDA213361
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 29 March 2022
- Application: ANDA216067
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 November 2022
- Application: ANDA216019
- Marketing authorisation holder: PHARMADAX
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 November 2022
- Application: ANDA216896
- Marketing authorisation holder: ALEMBIC
- Local brand name: NIFEDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Procardia 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 Procardia approved in United States?
Yes. FDA authorised it on 31 December 1981; FDA authorised it on 28 April 1989; FDA authorised it on 28 April 1989.
Who is the marketing authorisation holder for Procardia in United States?
PFIZER holds the US marketing authorisation.