🇺🇸 Enteric Coated Mycophenolate Sodium in United States

FDA authorised Enteric Coated Mycophenolate Sodium on 27 February 2004 · 1 US adverse-event reports

Marketing authorisations

FDA — authorised 27 February 2004

  • Application: NDA050791
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: MYFORTIC
  • Indication: TABLET, DELAYED RELEASE — ORAL
  • Status: approved

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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. Drug Ineffective — 1 report (100%)

Source database →

Enteric Coated Mycophenolate Sodium 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 Enteric Coated Mycophenolate Sodium approved in United States?

Yes. FDA authorised it on 27 February 2004; FDA has authorised it.

Who is the marketing authorisation holder for Enteric Coated Mycophenolate Sodium in United States?

NOVARTIS holds the US marketing authorisation.