🇺🇸 MEROPENEM in United States

FDA authorised MEROPENEM on 19 April 2016 · 19,176 US adverse-event reports

Marketing authorisations

FDA — authorised 19 April 2016

  • Application: ANDA206086
  • Marketing authorisation holder: SAVIOR LIFETEC CORP
  • Status: approved

FDA — authorised 8 June 2016

  • Application: ANDA206141
  • Marketing authorisation holder: GLAND
  • Status: supplemented

FDA — authorised 27 March 2017

  • Application: ANDA205835
  • Marketing authorisation holder: EUGIA PHARMA
  • Status: supplemented

FDA — authorised 22 July 2024

  • Application: ANDA216424
  • Marketing authorisation holder: QILU
  • Status: approved

FDA — authorised 23 June 2025

  • Application: ANDA219084
  • Marketing authorisation holder: BROOKS STERISCIENCE
  • Status: approved

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 4,323 reports (22.54%)
  2. Off Label Use — 3,191 reports (16.64%)
  3. Pyrexia — 2,254 reports (11.75%)
  4. Pneumonia — 1,567 reports (8.17%)
  5. Sepsis — 1,470 reports (7.67%)
  6. Septic Shock — 1,431 reports (7.46%)
  7. Acute Kidney Injury — 1,278 reports (6.66%)
  8. Multiple Organ Dysfunction Syndrome — 1,246 reports (6.5%)
  9. Condition Aggravated — 1,241 reports (6.47%)
  10. Respiratory Failure — 1,175 reports (6.13%)

Source database →

MEROPENEM in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is MEROPENEM approved in United States?

Yes. FDA authorised it on 19 April 2016; FDA authorised it on 8 June 2016; FDA authorised it on 27 March 2017.

Who is the marketing authorisation holder for MEROPENEM in United States?

SAVIOR LIFETEC CORP holds the US marketing authorisation.