FDA — authorised 5 August 2008
- Application: NDA050817
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Type 3 - New Dosage Form
- Status: approved
🇺🇸 Maxipime in United States
FDA authorised Maxipime on 5 August 2008
Marketing authorisations
FDA — authorised 6 September 2012
- Application: NDA050821
- Marketing authorisation holder: B BRAUN
- Indication: Labeling
- Status: approved
FDA — authorised 21 August 2018
- Application: ANDA209408
- Marketing authorisation holder: SAMSON MEDCL
- Status: approved
FDA — authorised 25 May 2020
- Application: ANDA065441
- Marketing authorisation holder: ACS DOBFAR
- Indication: Labeling
- Status: approved
FDA — authorised 22 May 2024
- Application: ANDA214402
- Marketing authorisation holder: HIKMA
- Status: approved
Maxipime 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 Maxipime approved in United States?
Yes. FDA authorised it on 5 August 2008; FDA authorised it on 6 September 2012; FDA authorised it on 21 August 2018.
Who is the marketing authorisation holder for Maxipime in United States?
BAXTER HLTHCARE holds the US marketing authorisation.