🇺🇸 Fexofenadine HCl + Pseudoephedrine HCl in United States

1 US adverse-event reports

Marketing authorisation

FDA

  • Application: ANDA076538
  • Marketing authorisation holder: MYLAN
  • Local brand name: FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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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. Angioedema — 1 report (100%)

Source database →

Other Allergy/Immunology approved in United States

Frequently asked questions

Is Fexofenadine HCl + Pseudoephedrine HCl approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Fexofenadine HCl + Pseudoephedrine HCl in United States?

MYLAN holds the US marketing authorisation.