FDA — authorised 18 January 1996
- Application: NDA050679
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: MAXIPIME
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Maxipime in United States
FDA authorised Maxipime on 18 January 1996
Marketing authorisations
FDA — authorised 6 September 2012
- Application: NDA050821
- Marketing authorisation holder: B BRAUN
- Indication: Labeling
- Status: approved
FDA — authorised 15 August 2017
- Application: ANDA203704
- Marketing authorisation holder: QILU ANTIBIOTICS
- Indication: Labeling
- 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 18 January 1996; FDA authorised it on 6 September 2012; FDA authorised it on 15 August 2017.
Who is the marketing authorisation holder for Maxipime in United States?
HOSPIRA INC holds the US marketing authorisation.