FDA — authorised 21 June 1996
- Application: NDA050706
- Marketing authorisation holder: PFIZER
- Local brand name: MERREM IV
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Merrem in United States
FDA authorised Merrem on 21 June 1996
Marketing authorisations
FDA — authorised 22 June 2010
- Application: ANDA090940
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: MEROPENEM
- Indication: INJECTABLE — INJECTION
- Status: approved
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 19 April 2016
- Application: ANDA206086
- Marketing authorisation holder: SAVIOR LIFETEC CORP
- Local brand name: MEROPENEM
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Merrem, a drug product, for labeling indication. This approval was granted to Savior Lifetec Corp on March 11, 2026. The application number for this approval is ANDA206086. Merrem was approved through the standard expedited pathway.
FDA — authorised 8 June 2016
- Application: ANDA206141
- Marketing authorisation holder: GLAND
- Local brand name: MEROPENEM
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Merrem, a drug for labeling indication, on August 21, 2025. The approval was granted to GLAND, the marketing authorisation holder, through a standard expedited pathway. The application number for this approval is ANDA206141.
FDA — authorised 9 June 2016
- Application: ANDA204139
- Marketing authorisation holder: ACS DOBFAR SPA
- Local brand name: MEROPENEM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 July 2019
- Application: ANDA091404
- Marketing authorisation holder: ACS DOBFAR
- Indication: Labeling
- 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
FDA — authorised 23 June 2025
- Application: ANDA219084
- Marketing authorisation holder: BROOKS STERISCIENCE
- Local brand name: MEROPENEM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 July 2025
- Application: ANDA205835
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Merrem, a drug product, for its approved labeling on July 25, 2025. The marketing authorization was granted to EUGIA PHARMA. The approval was made through the standard expedited pathway.
Merrem in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Merrem approved in United States?
Yes. FDA authorised it on 21 June 1996; FDA authorised it on 22 June 2010; FDA authorised it on 29 March 2011.
Who is the marketing authorisation holder for Merrem in United States?
PFIZER holds the US marketing authorisation.