FDA — authorised 27 January 2006
- Marketing authorisation holder: GILEAD
- Status: approved
🇺🇸 Ranexa in United States
FDA authorised Ranexa on 27 January 2006
Marketing authorisations
FDA — authorised 29 July 2013
- Application: ANDA201046
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 May 2019
- Application: ANDA210054
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 May 2019
- Application: ANDA211707
- Marketing authorisation holder: SUN PHARM
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 June 2019
- Application: ANDA211829
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 July 2019
- Application: ANDA211082
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 August 2019
- Application: ANDA210188
- Marketing authorisation holder: CADILA
- Status: approved
FDA — authorised 29 October 2019
- Application: ANDA210482
- Marketing authorisation holder: ANI PHARMS
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 February 2020
- Application: ANDA212284
- Marketing authorisation holder: MANKIND PHARMA
- Status: approved
FDA — authorised 27 February 2020
- Application: ANDA211745
- Marketing authorisation holder: MICRO LABS
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 March 2020
- Application: ANDA208862
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Indication: Labeling
- Status: approved
FDA — authorised 23 March 2020
- Application: ANDA212781
- Marketing authorisation holder: ARTHUR GRP
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 January 2021
- Application: ANDA212889
- Marketing authorisation holder: RISING
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 January 2022
- Application: ANDA214035
- Marketing authorisation holder: VKT PHARMA
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 February 2022
- Application: NDA216018
- Marketing authorisation holder: SPIL
- Local brand name: ASPRUZYO SPRINKLE
- Indication: GRANULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 April 2022
- Application: ANDA213517
- Marketing authorisation holder: I3 PHARMS
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 May 2022
- Application: ANDA212788
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 December 2022
- Application: ANDA209081
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 March 2023
- Application: ANDA213083
- Marketing authorisation holder: UNICHEM
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 July 2023
- Application: ANDA213085
- Marketing authorisation holder: PIRAMAL
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 September 2023
- Application: ANDA210668
- Marketing authorisation holder: NOVAST LABS
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 February 2025
- Application: ANDA210407
- Marketing authorisation holder: TORRENT
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA211361
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA208174
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: RANOLAZINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Ranexa 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 Ranexa approved in United States?
Yes. FDA authorised it on 27 January 2006; FDA authorised it on 29 July 2013; FDA authorised it on 28 May 2019.
Who is the marketing authorisation holder for Ranexa in United States?
GILEAD holds the US marketing authorisation.