🇺🇸 Saline solution ("B") in United States

FDA authorised Saline solution ("B") on 14 October 2009 · 1,640,701 US adverse-event reports

Marketing authorisations

FDA — authorised 14 October 2009

  • Application: ANDA078418
  • Marketing authorisation holder: STRIDES PHARMA
  • Status: supplemented

FDA — authorised 19 December 2014

  • Application: ANDA202693
  • Marketing authorisation holder: AVET LIFESCIENCES
  • Status: supplemented

FDA — authorised 15 September 2020

  • Application: ANDA205360
  • Marketing authorisation holder: AVET
  • Status: approved

FDA — authorised 29 August 2023

  • Application: ANDA212634
  • Marketing authorisation holder: STRIDES PHARMA INTL
  • 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 — 250,970 reports (15.3%)
  2. Off Label Use — 189,488 reports (11.55%)
  3. Fatigue — 188,686 reports (11.5%)
  4. Nausea — 186,536 reports (11.37%)
  5. Diarrhoea — 161,292 reports (9.83%)
  6. Dyspnoea — 147,047 reports (8.96%)
  7. Pain — 137,303 reports (8.37%)
  8. Headache — 136,958 reports (8.35%)
  9. Vomiting — 122,147 reports (7.44%)
  10. Dizziness — 120,274 reports (7.33%)

Source database →

Other General supportive care / Fluid and electrolyte management approved in United States

Frequently asked questions

Is Saline solution ("B") approved in United States?

Yes. FDA authorised it on 14 October 2009; FDA authorised it on 19 December 2014; FDA authorised it on 15 September 2020.

Who is the marketing authorisation holder for Saline solution ("B") in United States?

STRIDES PHARMA holds the US marketing authorisation.