FDA — authorised 5 September 2019
- Application: ANDA204015
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 FOSAPREPITANT DIMEGLUMINE in United States
FDA authorised FOSAPREPITANT DIMEGLUMINE on 5 September 2019
Marketing authorisations
FDA — authorised 5 September 2019
- Application: ANDA211860
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 5 September 2019
- Application: ANDA210689
- Marketing authorisation holder: LUPIN
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 5 September 2019
- Application: NDA210064
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 5 September 2019
- Application: ANDA209965
- Marketing authorisation holder: MSN
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 20 August 2020
- Application: ANDA212957
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 26 August 2020
- Application: ANDA204025
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 8 September 2020
- Application: ANDA213106
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 8 December 2020
- Application: ANDA203939
- Marketing authorisation holder: CAPLIN
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 9 December 2020
- Application: ANDA211160
- Marketing authorisation holder: DR REDDYS
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 12 January 2021
- Application: ANDA210625
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 3 March 2021
- Application: ANDA212143
- Marketing authorisation holder: CHIA TAI TIANQING
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 29 July 2021
- Application: ANDA214616
- Marketing authorisation holder: ASPIRO
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 4 October 2021
- Application: ANDA213199
- Marketing authorisation holder: PRAXGEN
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 22 August 2023
- Application: NDA216686
- Marketing authorisation holder: STERISCIENCE
- Local brand name: FOCINVEZ
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The FDA approved FOSAPREPITANT DIMEGLUMINE, a medication developed by STERISCIENCE, on 29 May 2025. The approval was granted under the standard expedited pathway. The approved indication for FOSAPREPITANT DIMEGLUMINE is listed in its labelling, but the specific indication is not specified in the available data.
FDA
- Application: ANDA204845
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: FOSAPREPITANT DIMEGLUMINE
- Indication: UNKNOWN — UNKNOWN
- Status: approved
FOSAPREPITANT DIMEGLUMINE 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 FOSAPREPITANT DIMEGLUMINE approved in United States?
Yes. FDA authorised it on 5 September 2019; FDA authorised it on 5 September 2019; FDA authorised it on 5 September 2019.
Who is the marketing authorisation holder for FOSAPREPITANT DIMEGLUMINE in United States?
MYLAN LABS LTD holds the US marketing authorisation.