FDA — authorised 16 November 2018
- Application: NDA210910
- Marketing authorisation holder: COSMO TECHNOLOGIES
- Local brand name: AEMCOLO
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA authorised Rifamycin SV MMX on 16 November 2018
Yes. FDA authorised it on 16 November 2018.
COSMO TECHNOLOGIES holds the US marketing authorisation.