🇺🇸 DIPHENHYDRAMINE CITRATE in United States

FDA authorised DIPHENHYDRAMINE CITRATE on 21 December 2005 · 1,381 US adverse-event reports

Marketing authorisations

FDA — authorised 21 December 2005

  • Application: NDA021394
  • Marketing authorisation holder: HALEON US HOLDINGS
  • Status: supplemented

FDA — authorised 8 July 2009

  • Application: ANDA090619
  • Marketing authorisation holder: DR REDDYS LABS LTD
  • Status: approved

FDA — authorised 31 May 2022

  • Application: ANDA216204
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Status: approved

FDA — authorised 11 April 2024

  • Application: ANDA211404
  • Marketing authorisation holder: PLD ACQUISITIONS LLC
  • 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. Product Use In Unapproved Indication — 422 reports (30.56%)
  2. Drug Effective For Unapproved Indication — 385 reports (27.88%)
  3. Somnolence — 134 reports (9.7%)
  4. Drug Ineffective — 101 reports (7.31%)
  5. Off Label Use — 85 reports (6.15%)
  6. Completed Suicide — 61 reports (4.42%)
  7. Incorrect Dose Administered — 55 reports (3.98%)
  8. Product Name Confusion — 50 reports (3.62%)
  9. Underdose — 46 reports (3.33%)
  10. Fatigue — 42 reports (3.04%)

Source database →

DIPHENHYDRAMINE CITRATE 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 DIPHENHYDRAMINE CITRATE approved in United States?

Yes. FDA authorised it on 21 December 2005; FDA authorised it on 8 July 2009; FDA authorised it on 31 May 2022.

Who is the marketing authorisation holder for DIPHENHYDRAMINE CITRATE in United States?

HALEON US HOLDINGS holds the US marketing authorisation.