🇺🇸 Pentam in United States

FDA authorised Pentam on 16 October 1984

Marketing authorisations

FDA — authorised 16 October 1984

  • Marketing authorisation holder: FRESENIUS KABI USA
  • Status: approved

FDA — authorised 16 October 1984

  • Application: NDA019264
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: PENTAM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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Pentam in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Pentam approved in United States?

Yes. FDA authorised it on 16 October 1984; FDA authorised it on 16 October 1984.

Who is the marketing authorisation holder for Pentam in United States?

FRESENIUS KABI USA holds the US marketing authorisation.