🇺🇸 Lamotrigine Generic "A" in United States

FDA authorised Lamotrigine Generic "A" on 1 October 2004 · 1,832,094 US adverse-event reports

Marketing authorisations

FDA — authorised 1 October 2004

  • Application: NDA021735
  • Marketing authorisation holder: FOUGERA PHARMS INC
  • Status: supplemented

FDA — authorised 14 October 2009

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

FDA — authorised 10 November 2010

  • Application: BLA022505
  • Marketing authorisation holder: THERATECHNOLOGIES
  • 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 — 307,029 reports (16.76%)
  2. Off Label Use — 236,904 reports (12.93%)
  3. Nausea — 198,748 reports (10.85%)
  4. Fatigue — 195,886 reports (10.69%)
  5. Diarrhoea — 177,794 reports (9.7%)
  6. Dyspnoea — 167,404 reports (9.14%)
  7. Headache — 149,814 reports (8.18%)
  8. Pain — 144,153 reports (7.87%)
  9. Vomiting — 128,177 reports (7%)
  10. Dizziness — 126,185 reports (6.89%)

Source database →

Other Neurology / Psychiatry approved in United States

Frequently asked questions

Is Lamotrigine Generic "A" approved in United States?

Yes. FDA authorised it on 1 October 2004; FDA authorised it on 14 October 2009; FDA authorised it on 10 November 2010.

Who is the marketing authorisation holder for Lamotrigine Generic "A" in United States?

FOUGERA PHARMS INC holds the US marketing authorisation.