FDA — authorised 12 August 2005
- Application: NDA021823
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: ACTONEL WITH CALCIUM (COPACKAGED)
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Oral Phosphate Supplement on 12 August 2005
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 12 August 2005; FDA has authorised it.
WARNER CHILCOTT holds the US marketing authorisation.