FDA — authorised 31 May 2013
- Application: NDA204078
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: BLOXIVERZ
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Bloxiverz in United States
FDA authorised Bloxiverz on 31 May 2013
Marketing authorisations
FDA — authorised 31 May 2013
- Marketing authorisation holder: ECLAT PHARMS LLC
- Status: approved
FDA — authorised 10 July 2018
- Application: ANDA209135
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 4 May 2022
- Application: ANDA212968
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
FDA — authorised 19 May 2022
- Application: ANDA209933
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Indication: Labeling
- Status: approved
FDA — authorised 31 May 2022
- Application: ANDA208405
- Marketing authorisation holder: PH HEALTH
- Indication: Labeling
- Status: approved
FDA — authorised 6 July 2022
- Application: ANDA216291
- Marketing authorisation holder: DR REDDYS
- Status: approved
Bloxiverz 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 Bloxiverz approved in United States?
Yes. FDA authorised it on 31 May 2013; FDA authorised it on 31 May 2013; FDA authorised it on 10 July 2018.
Who is the marketing authorisation holder for Bloxiverz in United States?
EXELA PHARMA holds the US marketing authorisation.