🇺🇸 CLARITHROMYCIN in United States

FDA authorised CLARITHROMYCIN on 25 August 2005 · 20,981 US adverse-event reports

Marketing authorisations

FDA — authorised 25 August 2005

  • Application: ANDA065136
  • Marketing authorisation holder: SANDOZ
  • Status: supplemented

FDA — authorised 20 August 2007

  • Application: ANDA065384
  • Marketing authorisation holder: CHARTWELL
  • Status: supplemented

FDA — authorised 4 September 2007

  • Application: ANDA065283
  • Marketing authorisation holder: SANDOZ
  • Status: supplemented

FDA — authorised 28 September 2015

  • Application: ANDA203584
  • Marketing authorisation holder: HEC PHARM
  • Status: supplemented

FDA — authorised 9 July 2018

  • Application: ANDA208987
  • Marketing authorisation holder: SUNSHINE
  • Status: supplemented

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 Interaction — 3,137 reports (14.95%)
  2. Drug Ineffective — 2,602 reports (12.4%)
  3. Nausea — 2,444 reports (11.65%)
  4. Dyspnoea — 2,167 reports (10.33%)
  5. Diarrhoea — 2,146 reports (10.23%)
  6. Malaise — 1,811 reports (8.63%)
  7. Pyrexia — 1,755 reports (8.36%)
  8. Headache — 1,698 reports (8.09%)
  9. Off Label Use — 1,616 reports (7.7%)
  10. Vomiting — 1,605 reports (7.65%)

Source database →

CLARITHROMYCIN 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 CLARITHROMYCIN approved in United States?

Yes. FDA authorised it on 25 August 2005; FDA authorised it on 20 August 2007; FDA authorised it on 4 September 2007.

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

SANDOZ holds the US marketing authorisation.