FDA — authorised 26 October 1984
- Application: NDA018983
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: COLYTE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA authorised Colyte on 26 October 1984
Yes. FDA authorised it on 26 October 1984.
STRIDES PHARMA INTL holds the US marketing authorisation.