🇺🇸 Tazorac Cream in United States

FDA authorised Tazorac Cream on 13 June 1997 · 36 US adverse-event reports

Marketing authorisations

FDA — authorised 13 June 1997

  • Application: NDA020600
  • Marketing authorisation holder: ALMIRALL
  • Local brand name: TAZORAC
  • Indication: GEL — TOPICAL
  • Status: approved

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FDA — authorised 29 September 2000

  • Application: NDA021184
  • Marketing authorisation holder: ALMIRALL
  • Local brand name: TAZORAC
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 3 April 2017

  • Application: ANDA208258
  • Marketing authorisation holder: SUN PHARMA CANADA
  • Local brand name: TAZAROTENE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 22 December 2017

  • Application: ANDA208662
  • Marketing authorisation holder: COSETTE
  • Local brand name: TAZAROTENE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 20 March 2023

  • Application: ANDA213644
  • Marketing authorisation holder: SOLARIS PHARMA CORP
  • Local brand name: TAZAROTENE
  • Indication: GEL — TOPICAL
  • Status: approved

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FDA — authorised 25 April 2023

  • Application: ANDA213079
  • Marketing authorisation holder: PADAGIS ISRAEL
  • Local brand name: TAZAROTENE
  • Indication: GEL — TOPICAL
  • Status: approved

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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. Erythema — 7 reports (19.44%)
  2. Pregnancy — 4 reports (11.11%)
  3. Skin Exfoliation — 4 reports (11.11%)
  4. Skin Irritation — 4 reports (11.11%)
  5. Acne — 3 reports (8.33%)
  6. Application Site Erythema — 3 reports (8.33%)
  7. Dry Skin — 3 reports (8.33%)
  8. Off Label Use — 3 reports (8.33%)
  9. Pruritus — 3 reports (8.33%)
  10. Feeling Hot — 2 reports (5.56%)

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Tazorac Cream 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 Tazorac Cream approved in United States?

Yes. FDA authorised it on 13 June 1997; FDA authorised it on 29 September 2000; FDA authorised it on 3 April 2017.

Who is the marketing authorisation holder for Tazorac Cream in United States?

ALMIRALL holds the US marketing authorisation.