🇺🇸 Thalomid in United States

FDA authorised Thalomid on 16 July 1998

Marketing authorisations

FDA — authorised 16 July 1998

  • Marketing authorisation holder: CELGENE
  • Status: approved

FDA — authorised 27 April 2023

  • Application: ANDA213267
  • Marketing authorisation holder: NATCO
  • Local brand name: THALIDOMIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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Thalomid in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Thalomid approved in United States?

Yes. FDA authorised it on 16 July 1998; FDA authorised it on 27 April 2023.

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

CELGENE holds the US marketing authorisation.