FDA — authorised 16 February 2001
- Application: NDA050781
- Marketing authorisation holder: ORAPHARMA
- Local brand name: ARESTIN
- Indication: POWDER, EXTENDED RELEASE — DENTAL
- Status: approved
FDA authorised Minocycline HCl Microspheres on 16 February 2001
Yes. FDA authorised it on 16 February 2001.
ORAPHARMA holds the US marketing authorisation.