🇺🇸 BUTENAFINE HYDROCHLORIDE in United States

FDA authorised BUTENAFINE HYDROCHLORIDE on 17 October 2002 · 47 US adverse-event reports

Marketing authorisations

FDA — authorised 17 October 2002

  • Application: NDA021408
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: MENTAX-TC
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 16 November 2017

  • Application: ANDA205181
  • Marketing authorisation holder: SUN PHARMA CANADA
  • Local brand name: BUTENAFINE HYDROCHLORIDE
  • Indication: CREAM — TOPICAL
  • Status: approved

Read official source →

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. Drug Ineffective — 16 reports (34.04%)
  2. Condition Aggravated — 5 reports (10.64%)
  3. Application Site Pain — 4 reports (8.51%)
  4. Aspartate Aminotransferase Increased — 4 reports (8.51%)
  5. Alanine Aminotransferase Increased — 3 reports (6.38%)
  6. Blood Creatinine Increased — 3 reports (6.38%)
  7. Cerebral Infarction — 3 reports (6.38%)
  8. Gait Disturbance — 3 reports (6.38%)
  9. Nausea — 3 reports (6.38%)
  10. Off Label Use — 3 reports (6.38%)

Source database →

BUTENAFINE HYDROCHLORIDE 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 BUTENAFINE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 17 October 2002; FDA authorised it on 16 November 2017; FDA has authorised it.

Who is the marketing authorisation holder for BUTENAFINE HYDROCHLORIDE in United States?

PHARMOBEDIENT holds the US marketing authorisation.