🇺🇸 BENZOYL PEROXIDE/ CLINDAMYCIN in United States

FDA authorised BENZOYL PEROXIDE/ CLINDAMYCIN on 28 April 2021 · 529 US adverse-event reports

Marketing authorisation

FDA — authorised 28 April 2021

  • Application: ANDA212433
  • Marketing authorisation holder: ENCUBE
  • 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. Abortion Spontaneous — 170 reports (32.14%)
  2. Maternal Exposure During Pregnancy — 145 reports (27.41%)
  3. Drug Ineffective — 51 reports (9.64%)
  4. Exposure During Pregnancy — 34 reports (6.43%)
  5. Rash — 29 reports (5.48%)
  6. Diarrhoea — 23 reports (4.35%)
  7. Off Label Use — 23 reports (4.35%)
  8. Erythema — 20 reports (3.78%)
  9. Dry Skin — 17 reports (3.21%)
  10. Pruritus — 17 reports (3.21%)

Source database →

Other Dermatology approved in United States

Frequently asked questions

Is BENZOYL PEROXIDE/ CLINDAMYCIN approved in United States?

Yes. FDA authorised it on 28 April 2021.

Who is the marketing authorisation holder for BENZOYL PEROXIDE/ CLINDAMYCIN in United States?

ENCUBE holds the US marketing authorisation.