FDA — authorised 26 December 2006
- Application: ANDA077406
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: ONDANSETRON
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
🇺🇸 Zofran® in United States
FDA authorised Zofran® on 26 December 2006
Marketing authorisations
FDA — authorised 25 June 2007
- Application: ANDA078139
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ONDANSETRON
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 25 June 2007
- Application: ANDA076810
- Marketing authorisation holder: TEVA
- Local brand name: ONDANSETRON
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 27 June 2007
- Application: ANDA078152
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ONDANSETRON
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 2 August 2007
- Application: ANDA077557
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: ONDANSETRON
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 13 August 2007
- Application: ANDA078050
- Marketing authorisation holder: SANDOZ
- Local brand name: ONDANSETRON
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 18 November 2008
- Application: ANDA079032
- Marketing authorisation holder: AM REGENT
- Local brand name: ONDANSETRON
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 April 2010
- Application: ANDA090469
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ONDANSETRON
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 24 February 2011
- Application: ANDA078602
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: ONDANSETRON
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 30 October 2023
- Application: ANDA209389
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: ONDANSETRON
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA
- Application: ANDA077717
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: ONDANSETRON
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA
- Status: approved
Zofran® in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Zofran® approved in United States?
Yes. FDA authorised it on 26 December 2006; FDA authorised it on 25 June 2007; FDA authorised it on 25 June 2007.
Who is the marketing authorisation holder for Zofran® in United States?
CHARTWELL MOLECULES holds the US marketing authorisation.