FDA — authorised 18 May 2000
- Application: NDA021163
- Marketing authorisation holder: SANDOZ CANADA INC
- Local brand name: INFUVITE ADULT
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Infuvite Adult in United States
FDA authorised Infuvite Adult on 18 May 2000
Marketing authorisations
FDA — authorised 2 December 2015
- Application: NDA021265
- Marketing authorisation holder: SANDOZ CANADA INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 17 December 2019
- Application: ANDA090145
- Marketing authorisation holder: NOVEL LABS INC
- Indication: Labeling
- Status: approved
FDA — authorised 23 April 2023
- Application: NDA209112
- Marketing authorisation holder: MCGUFF
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 8 September 2023
- Application: NDA209381
- Marketing authorisation holder: SALIX
- Indication: Labeling
- Status: approved
FDA — authorised 7 August 2025
- Application: ANDA217131
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
Infuvite Adult in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Infuvite Adult approved in United States?
Yes. FDA authorised it on 18 May 2000; FDA authorised it on 2 December 2015; FDA authorised it on 17 December 2019.
Who is the marketing authorisation holder for Infuvite Adult in United States?
SANDOZ CANADA INC holds the US marketing authorisation.