FDA — authorised 15 June 2004
- Application: NDA021636
- Marketing authorisation holder: SALIX
- Status: supplemented
FDA authorised Zegerid on 15 June 2004
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 15 June 2004; FDA authorised it on 27 February 2006; FDA authorised it on 1 December 2009.
SALIX holds the US marketing authorisation.