🇺🇸 Elimite in United States

FDA authorised Elimite on 31 March 1986

Marketing authorisations

FDA — authorised 31 March 1986

  • Status: approved

FDA — authorised 2 May 1990

  • Application: NDA019918
  • Marketing authorisation holder: MEDTECH PRODUCTS
  • Local brand name: NIX
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA — authorised 4 September 2001

  • Application: ANDA074806
  • Marketing authorisation holder: ACTAVIS LABS
  • Indication: Manufacturing (CMC)
  • Status: approved

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FDA — authorised 20 December 2001

  • Application: ANDA076090
  • Marketing authorisation holder: PERRIGO NEW YORK
  • Local brand name: PERMETHRIN
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA — authorised 21 April 2003

  • Application: ANDA076369
  • Marketing authorisation holder: PADAGIS ISRAEL
  • Status: approved

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FDA — authorised 3 April 2019

  • Application: ANDA211303
  • Marketing authorisation holder: ENCUBE ETHICALS
  • Status: approved

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FDA — authorised 1 August 2023

  • Application: ANDA209732
  • Marketing authorisation holder: DR REDDYS LABS EU
  • Local brand name: PERMETHRIN
  • Indication: CREAM — TOPICAL
  • Status: approved

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Elimite in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Elimite approved in United States?

Yes. FDA authorised it on 31 March 1986; FDA authorised it on 2 May 1990; FDA authorised it on 4 September 2001.

Who is the marketing authorisation holder for Elimite in United States?

Marketing authorisation holder not available in our data.