FDA — authorised 21 June 1996
- Application: NDA050706
- Marketing authorisation holder: PFIZER
- Local brand name: MERREM IV
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Carbapenems in United States
FDA authorised Carbapenems on 21 June 1996
Marketing authorisations
FDA — authorised 29 March 2011
- Application: ANDA091201
- Marketing authorisation holder: SANDOZ
- Local brand name: MEROPENEM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 2015
- Application: NDA202106
- Marketing authorisation holder: B BRAUN MEDICAL
- Local brand name: MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 18 December 2015
- Application: ANDA204854
- Marketing authorisation holder: DAEWOONG PHARM CO
- Local brand name: MEROPENEM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 April 2016
- Application: ANDA205883
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: MEROPENEM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 August 2019
- Application: ANDA210773
- Marketing authorisation holder: HQ SPCLT PHARMA
- Local brand name: MEROPENEM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 August 2022
- Application: ANDA216154
- Marketing authorisation holder: BROOKS STERISCIENCE
- Local brand name: MEROPENEM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 July 2023
- Application: NDA215212
- Marketing authorisation holder: HQ SPCLT PHARMA
- Local brand name: MEROPENEM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 22 July 2024
- Application: ANDA216424
- Marketing authorisation holder: QILU
- Local brand name: MEROPENEM
- Indication: INJECTABLE — INJECTION
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Carbapenems approved in United States?
Yes. FDA authorised it on 21 June 1996; FDA authorised it on 29 March 2011; FDA authorised it on 30 April 2015.
Who is the marketing authorisation holder for Carbapenems in United States?
PFIZER holds the US marketing authorisation.