🇺🇸 Succinylcholine in United States

FDA authorised Succinylcholine on 20 August 1952 · 2,321 US adverse-event reports

Marketing authorisations

FDA — authorised 20 August 1952

  • Application: NDA008453
  • Marketing authorisation holder: SANDOZ
  • Local brand name: ANECTINE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 4 June 2018

  • Application: ANDA210231
  • Marketing authorisation holder: AMRING PHARMS
  • Status: supplemented

FDA — authorised 15 January 2020

  • Application: ANDA211589
  • Marketing authorisation holder: SOMERSET THERAPS LLC
  • Status: supplemented

FDA — authorised 4 May 2020

  • Application: ANDA213810
  • Marketing authorisation holder: ASPIRO
  • Status: supplemented

FDA — authorised 22 May 2020

  • Application: ANDA214308
  • Marketing authorisation holder: REGCON HOLDINGS
  • Status: supplemented

FDA — authorised 16 June 2020

  • Application: ANDA214246
  • Marketing authorisation holder: GLAND
  • 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 — 399 reports (17.19%)
  2. Hypotension — 319 reports (13.74%)
  3. Hyperthermia Malignant — 299 reports (12.88%)
  4. Cardiac Arrest — 268 reports (11.55%)
  5. Drug Interaction — 228 reports (9.82%)
  6. Anaphylactic Shock — 213 reports (9.18%)
  7. Anaphylactic Reaction — 192 reports (8.27%)
  8. Maternal Exposure During Pregnancy — 136 reports (5.86%)
  9. Bradycardia — 134 reports (5.77%)
  10. Foetal Exposure During Pregnancy — 133 reports (5.73%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Succinylcholine approved in United States?

Yes. FDA authorised it on 20 August 1952; FDA authorised it on 4 June 2018; FDA authorised it on 15 January 2020.

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

SANDOZ holds the US marketing authorisation.