FDA — authorised 10 December 2001
- Application: ANDA060593
- Marketing authorisation holder: SANALUZ
- Indication: Labeling
- Status: approved
FDA authorised Cyclorin on 10 December 2001
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 10 December 2001.
SANALUZ holds the US marketing authorisation.