🇺🇸 SL Buprenorphine in United States

FDA authorised SL Buprenorphine on 8 October 2002

Marketing authorisations

FDA — authorised 8 October 2002

  • Application: NDA020732
  • Marketing authorisation holder: INDIVIOR
  • Local brand name: SUBUTEX
  • Indication: TABLET — SUBLINGUAL
  • Status: approved

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FDA

  • Status: approved

SL Buprenorphine 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 SL Buprenorphine approved in United States?

Yes. FDA authorised it on 8 October 2002; FDA has authorised it.

Who is the marketing authorisation holder for SL Buprenorphine in United States?

INDIVIOR holds the US marketing authorisation.