🇺🇸 Nasal Decongestant in United States

FDA authorised Nasal Decongestant on 26 February 1999 · 298 US adverse-event reports

Marketing authorisations

FDA — authorised 26 February 1999

  • Application: ANDA075153
  • Marketing authorisation holder: L PERRIGO CO
  • Status: supplemented

FDA — authorised 28 September 2005

  • Application: ANDA077442
  • Marketing authorisation holder: SUN PHARM INDS LTD
  • Status: approved

FDA — authorised 16 November 2018

  • Application: ANDA210719
  • Marketing authorisation holder: PPI-DAC
  • 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 — 42 reports (14.09%)
  2. Off Label Use — 38 reports (12.75%)
  3. Drug Ineffective — 37 reports (12.42%)
  4. Drug Administered To Patient Of Inappropriate Age — 29 reports (9.73%)
  5. Product Use Issue — 28 reports (9.4%)
  6. Therapeutic Response Unexpected — 28 reports (9.4%)
  7. Incorrect Dose Administered — 26 reports (8.72%)
  8. Dyspnoea — 24 reports (8.05%)
  9. Insomnia — 24 reports (8.05%)
  10. Fatigue — 22 reports (7.38%)

Source database →

Frequently asked questions

Is Nasal Decongestant approved in United States?

Yes. FDA authorised it on 26 February 1999; FDA authorised it on 28 September 2005; FDA authorised it on 16 November 2018.

Who is the marketing authorisation holder for Nasal Decongestant in United States?

L PERRIGO CO holds the US marketing authorisation.