🇺🇸 Nicotine Mini in United States

FDA authorised Nicotine Mini on 9 October 2012 · 41 US adverse-event reports

Marketing authorisations

FDA — authorised 9 October 2012

  • Application: ANDA203690
  • Marketing authorisation holder: PPI-DAC
  • Status: supplemented

FDA — authorised 7 February 2019

  • Application: ANDA207868
  • Marketing authorisation holder: PLD ACQUISITIONS
  • Status: approved

FDA — authorised 31 October 2019

  • Application: ANDA208875
  • Marketing authorisation holder: P AND L
  • Status: approved

FDA — authorised 31 October 2019

  • Application: ANDA210711
  • Marketing authorisation holder: P AND L
  • Status: approved

FDA — authorised 14 May 2020

  • Application: ANDA212057
  • Marketing authorisation holder: P AND L
  • 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. Nausea — 9 reports (21.95%)
  2. Hiccups — 6 reports (14.63%)
  3. Wrong Technique In Product Usage Process — 6 reports (14.63%)
  4. No Adverse Event — 4 reports (9.76%)
  5. Vomiting — 4 reports (9.76%)
  6. Blood Pressure Increased — 3 reports (7.32%)
  7. Oral Discomfort — 3 reports (7.32%)
  8. Accidental Exposure To Product — 2 reports (4.88%)
  9. Device Related Bacteraemia — 2 reports (4.88%)
  10. Drug Ineffective — 2 reports (4.88%)

Source database →

Other Smoking Cessation / Addiction Medicine approved in United States

Frequently asked questions

Is Nicotine Mini approved in United States?

Yes. FDA authorised it on 9 October 2012; FDA authorised it on 7 February 2019; FDA authorised it on 31 October 2019.

Who is the marketing authorisation holder for Nicotine Mini in United States?

PPI-DAC holds the US marketing authorisation.