FDA — authorised 5 February 2001
- Application: NDA020825
- Marketing authorisation holder: VIATRIS
- Local brand name: GEODON
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Geodon in United States
FDA authorised Geodon on 5 February 2001
Marketing authorisations
FDA — authorised 21 June 2002
- Application: NDA020919
- Marketing authorisation holder: VIATRIS
- Local brand name: GEODON
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA — authorised 29 March 2006
- Application: NDA021483
- Marketing authorisation holder: PFIZER INC
- Local brand name: GEODON
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 September 2012
- Application: ANDA090348
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 29 November 2019
- Application: ANDA204117
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 2 February 2021
- Application: ANDA211908
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
FDA — authorised 3 September 2025
- Application: ANDA217595
- Marketing authorisation holder: STERISCIENCE
- Status: approved
Geodon 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 Geodon approved in United States?
Yes. FDA authorised it on 5 February 2001; FDA authorised it on 21 June 2002; FDA authorised it on 29 March 2006.
Who is the marketing authorisation holder for Geodon in United States?
VIATRIS holds the US marketing authorisation.