🇺🇸 cholecalciferol and calcium carbonate in United States

FDA authorised cholecalciferol and calcium carbonate on 12 August 2005 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 12 August 2005

  • Application: NDA021823
  • Marketing authorisation holder: WARNER CHILCOTT
  • Local brand name: ACTONEL WITH CALCIUM (COPACKAGED)
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Atrial Fibrillation — 1 report (10%)
  2. Cardiac Arrest — 1 report (10%)
  3. Drug Exposure During Pregnancy — 1 report (10%)
  4. Dysphagia — 1 report (10%)
  5. Gastric Ulcer — 1 report (10%)
  6. Haematemesis — 1 report (10%)
  7. Intra-Uterine Death — 1 report (10%)
  8. Oesophageal Ulcer — 1 report (10%)
  9. Sudden Cardiac Death — 1 report (10%)
  10. Syncope — 1 report (10%)

Source database →

cholecalciferol and calcium carbonate in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is cholecalciferol and calcium carbonate approved in United States?

Yes. FDA authorised it on 12 August 2005; FDA has authorised it.

Who is the marketing authorisation holder for cholecalciferol and calcium carbonate in United States?

WARNER CHILCOTT holds the US marketing authorisation.