🇺🇸 Zinc in United States

FDA authorised Zinc on 26 June 1986

Marketing authorisations

FDA — authorised 26 June 1986

  • Application: NDA018959
  • Marketing authorisation holder: HOSPIRA
  • Status: supplemented

FDA — authorised 11 August 2004

  • Application: NDA021751
  • Marketing authorisation holder: HAMELN PHARMA PLUS
  • Status: supplemented

FDA — authorised 21 May 2021

  • Application: ANDA212007
  • Marketing authorisation holder: EXELA PHARMA
  • Status: approved

FDA — authorised 10 June 2024

  • Application: ANDA218059
  • Marketing authorisation holder: APOTEX
  • Status: supplemented

FDA — authorised 17 July 2024

  • Application: ANDA216135
  • Marketing authorisation holder: SOMERSET THERAPS LLC
  • Status: approved

Zinc 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 Zinc approved in United States?

Yes. FDA authorised it on 26 June 1986; FDA authorised it on 11 August 2004; FDA authorised it on 21 May 2021.

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

HOSPIRA holds the US marketing authorisation.