FDA — authorised 25 July 1991
- Marketing authorisation holder: ASTRAZENECA
- Status: approved
🇺🇸 Plendil in United States
FDA authorised Plendil on 25 July 1991
Marketing authorisations
FDA — authorised 2 November 2004
- Application: ANDA075896
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 April 2008
- Application: ANDA078855
- Marketing authorisation holder: MYLAN
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 December 2010
- Application: ANDA090365
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 October 2011
- Application: ANDA200815
- Marketing authorisation holder: PH HEALTH
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 November 2011
- Application: ANDA202170
- Marketing authorisation holder: TORRENT PHARMS LTD
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 August 2012
- Application: ANDA091484
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 January 2013
- Application: ANDA203417
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 November 2013
- Application: ANDA201964
- Marketing authorisation holder: HERITAGE
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 December 2013
- Application: ANDA091200
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 May 2015
- Application: ANDA203032
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 August 2016
- Application: ANDA203983
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 October 2018
- Application: ANDA210847
- Marketing authorisation holder: YILING
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 April 2019
- Application: ANDA204800
- Marketing authorisation holder: YUNG SHIN PHARM
- Local brand name: FELODIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Plendil 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 Plendil approved in United States?
Yes. FDA authorised it on 25 July 1991; FDA authorised it on 2 November 2004; FDA authorised it on 17 April 2008.
Who is the marketing authorisation holder for Plendil in United States?
ASTRAZENECA holds the US marketing authorisation.