🇺🇸 Fluvastatin extended release tablet in United States

FDA authorised Fluvastatin extended release tablet on 6 October 2000

Marketing authorisations

FDA — authorised 6 October 2000

  • Application: NDA021192
  • Marketing authorisation holder: SANDOZ
  • Local brand name: LESCOL XL
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA

  • Status: approved

Fluvastatin extended release tablet 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 Fluvastatin extended release tablet approved in United States?

Yes. FDA authorised it on 6 October 2000; FDA has authorised it.

Who is the marketing authorisation holder for Fluvastatin extended release tablet in United States?

SANDOZ holds the US marketing authorisation.