FDA — authorised 12 January 2001
- Application: NDA021208
- Marketing authorisation holder: ORGANON USA ORGANON
- Local brand name: REMERON SOLTAB
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
🇺🇸 Remeron in United States
FDA authorised Remeron on 12 January 2001
Marketing authorisations
FDA — authorised 19 June 2003
- Application: ANDA076122
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 26 November 2007
- Application: ANDA076921
- Marketing authorisation holder: AUROBINDO
- Indication: Labeling
- Status: approved
FDA — authorised 1 June 2017
- Application: ANDA205798
- Marketing authorisation holder: SQUARE PHARMS PLC
- Status: approved
FDA — authorised 18 January 2023
- Application: ANDA216751
- Marketing authorisation holder: PRASCO
- Status: approved
FDA — authorised 2 October 2025
- Application: ANDA219721
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
Remeron in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Remeron approved in United States?
Yes. FDA authorised it on 12 January 2001; FDA authorised it on 19 June 2003; FDA authorised it on 26 November 2007.
Who is the marketing authorisation holder for Remeron in United States?
ORGANON USA ORGANON holds the US marketing authorisation.