FDA — authorised 18 August 2003
- Application: ANDA076453
- Marketing authorisation holder: FOUGERA PHARMS
- Indication: Supplement
- Status: approved
🇺🇸 Citanest in United States
FDA authorised Citanest on 18 August 2003
Marketing authorisations
FDA — authorised 27 August 2003
- Application: ANDA076320
- Marketing authorisation holder: ENCUBE
- Status: approved
FDA — authorised 30 August 2011
- Application: ANDA078959
- Marketing authorisation holder: SEPTODONT INC
- Status: approved
FDA — authorised 29 June 2018
- Application: ANDA205887
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: Citanest
- Status: approved
FDA — authorised 27 July 2021
- Application: ANDA212482
- Marketing authorisation holder: PADAGIS US
- Local brand name: Citanest
- Status: approved
FDA — authorised 8 April 2022
- Application: ANDA213923
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 17 December 2024
- Application: ANDA219120
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Status: approved
Citanest in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Citanest approved in United States?
Yes. FDA authorised it on 18 August 2003; FDA authorised it on 27 August 2003; FDA authorised it on 30 August 2011.
Who is the marketing authorisation holder for Citanest in United States?
FOUGERA PHARMS holds the US marketing authorisation.