🇺🇸 PHENYTOIN SODIUM in United States

FDA authorised PHENYTOIN SODIUM on 16 July 1975 · 2,854 US adverse-event reports

Marketing authorisations

FDA — authorised 16 July 1975

  • Application: ANDA084307
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 13 September 2006

  • Application: ANDA040573
  • Marketing authorisation holder: ACELLA
  • Status: approved

FDA — authorised 10 June 2015

  • Application: ANDA204309
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Status: supplemented

FDA — authorised 13 October 2022

  • Application: ANDA213834
  • Marketing authorisation holder: UNICHEM
  • Status: approved

FDA — authorised 2 January 2026

  • Application: ANDA219773
  • Marketing authorisation holder: MANKIND PHARMA
  • 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 — 676 reports (23.69%)
  2. Convulsion — 408 reports (14.3%)
  3. Seizure — 379 reports (13.28%)
  4. Drug Interaction — 316 reports (11.07%)
  5. Toxicity To Various Agents — 261 reports (9.15%)
  6. Fall — 177 reports (6.2%)
  7. Dizziness — 171 reports (5.99%)
  8. Epilepsy — 157 reports (5.5%)
  9. Pyrexia — 157 reports (5.5%)
  10. Stevens-Johnson Syndrome — 152 reports (5.33%)

Source database →

PHENYTOIN SODIUM 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 PHENYTOIN SODIUM approved in United States?

Yes. FDA authorised it on 16 July 1975; FDA authorised it on 13 September 2006; FDA authorised it on 10 June 2015.

Who is the marketing authorisation holder for PHENYTOIN SODIUM in United States?

HIKMA holds the US marketing authorisation.