FDA — authorised 16 August 1957
- Status: approved
🇺🇸 Propoxyphene Compound 65 in United States
FDA authorised Propoxyphene Compound 65 on 16 August 1957
Marketing authorisations
FDA — authorised 22 December 1970
- Application: ANDA080044
- Marketing authorisation holder: SANDOZ
- Local brand name: PROPOXYPHENE COMPOUND 65
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 June 1976
- Application: ANDA083101
- Marketing authorisation holder: SANDOZ
- Local brand name: PROPOXYPHENE COMPOUND-65
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 April 1978
- Application: ANDA083077
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PROPOXYPHENE COMPOUND 65
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 March 1985
- Application: ANDA089025
- Marketing authorisation holder: TEVA
- Local brand name: PROPOXYPHENE COMPOUND 65
- Indication: CAPSULE — ORAL
- 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 16 August 1957; FDA authorised it on 22 December 1970; FDA authorised it on 15 June 1976.
Who is the marketing authorisation holder for Propoxyphene Compound 65 in United States?
Marketing authorisation holder not available in our data.