FDA — authorised 9 July 1997
- Application: ANDA074878
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PENTOXIFYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Oxopurin in United States
FDA authorised Oxopurin on 9 July 1997
Marketing authorisations
FDA — authorised 31 March 1999
- Application: ANDA074962
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: PENTOXIL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 September 1999
- Application: ANDA075199
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PENTOXIFYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Oxopurin approved in United States?
Yes. FDA authorised it on 9 July 1997; FDA authorised it on 31 March 1999; FDA authorised it on 3 September 1999.
Who is the marketing authorisation holder for Oxopurin in United States?
ANI PHARMS holds the US marketing authorisation.