🇺🇸 LANTHANUM CARBONATE in United States

FDA authorised LANTHANUM CARBONATE on 26 October 2004

Marketing authorisations

FDA — authorised 26 October 2004

  • Application: NDA021468
  • Marketing authorisation holder: TAKEDA PHARMS USA
  • Status: supplemented

FDA — authorised 11 August 2017

  • Application: ANDA090978
  • Marketing authorisation holder: NATCO PHARMA LTD
  • Status: supplemented

FDA — authorised 24 January 2022

  • Application: ANDA206868
  • Marketing authorisation holder: INVAGEN PHARMS
  • Local brand name: LANTHANUM CARBONATE
  • Indication: TABLET, CHEWABLE — ORAL
  • Status: approved

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FDA — authorised 27 January 2022

  • Application: ANDA090977
  • Marketing authorisation holder: BARR
  • Status: approved

FDA — authorised 13 March 2025

  • Application: ANDA202329
  • Marketing authorisation holder: ALKEM LABS LTD
  • Status: approved

FDA

  • Status: approved

LANTHANUM CARBONATE 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 LANTHANUM CARBONATE approved in United States?

Yes. FDA authorised it on 26 October 2004; FDA authorised it on 11 August 2017; FDA authorised it on 24 January 2022.

Who is the marketing authorisation holder for LANTHANUM CARBONATE in United States?

TAKEDA PHARMS USA holds the US marketing authorisation.