🇺🇸 Propoxyphene Compound 65 in United States

FDA authorised Propoxyphene Compound 65 on 22 December 1970

Marketing authorisations

FDA — authorised 22 December 1970

  • Application: ANDA080044
  • Marketing authorisation holder: SANDOZ
  • Local brand name: PROPOXYPHENE COMPOUND 65
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 29 March 1985

  • Application: ANDA089025
  • Marketing authorisation holder: TEVA
  • Local brand name: PROPOXYPHENE COMPOUND 65
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA

  • Status: approved

Propoxyphene Compound 65 in other countries

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

Other Pain approved in United States

Frequently asked questions

Is Propoxyphene Compound 65 approved in United States?

Yes. FDA authorised it on 22 December 1970; FDA authorised it on 29 March 1985; FDA has authorised it.

Who is the marketing authorisation holder for Propoxyphene Compound 65 in United States?

SANDOZ holds the US marketing authorisation.