🇺🇸 Sodium Chloride 23.4% in United States

FDA authorised Sodium Chloride 23.4% on 20 July 1984 · 46,653 US adverse-event reports

Marketing authorisations

FDA — authorised 20 July 1984

  • Application: NDA018897
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: SODIUM CHLORIDE 23.4%
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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FDA — authorised 20 December 2019

  • Application: ANDA211190
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: Sodium Chloride 23.4%
  • Status: approved

FDA — authorised 26 August 2020

  • Application: ANDA211194
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: Sodium Chloride 23.4%
  • Status: approved

FDA — authorised 28 April 2021

  • Application: ANDA212070
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: SODIUM CHLORIDE 23.4%
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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FDA — authorised 28 April 2021

  • Application: ANDA212248
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: SODIUM CHLORIDE 23.4%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 11 July 2023

  • Application: ANDA217796
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: SODIUM CHLORIDE 23.4%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 16 October 2023

  • Application: ANDA217155
  • Marketing authorisation holder: AMNEAL
  • Local brand name: Sodium Chloride 23.4%
  • Status: approved

FDA — authorised 16 April 2024

  • Application: ANDA218599
  • Marketing authorisation holder: GLAND
  • Local brand name: Sodium Chloride 23.4%
  • 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. Nausea — 5,934 reports (12.72%)
  2. Dyspnoea — 5,423 reports (11.62%)
  3. Myelosuppression — 4,864 reports (10.43%)
  4. Pyrexia — 4,816 reports (10.32%)
  5. Off Label Use — 4,788 reports (10.26%)
  6. Headache — 4,553 reports (9.76%)
  7. Vomiting — 4,449 reports (9.54%)
  8. Fatigue — 4,149 reports (8.89%)
  9. Diarrhoea — 3,940 reports (8.45%)
  10. Pneumonia — 3,737 reports (8.01%)

Source database →

Sodium Chloride 23.4% 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 Sodium Chloride 23.4% approved in United States?

Yes. FDA authorised it on 20 July 1984; FDA authorised it on 20 December 2019; FDA authorised it on 26 August 2020.

Who is the marketing authorisation holder for Sodium Chloride 23.4% in United States?

HOSPIRA holds the US marketing authorisation.