🇺🇸 Aridol Kit in United States

FDA authorised Aridol Kit on 8 October 1965

Marketing authorisations

FDA — authorised 8 October 1965

  • Application: NDA016080
  • Marketing authorisation holder: B BRAUN
  • Local brand name: MANNITOL 10%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 22 December 1967

  • Application: NDA016269
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: MANNITOL 10%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Status: approved

FDA

  • Application: NDA016472
  • Marketing authorisation holder: MILES
  • Local brand name: MANNITOL 10%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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Aridol Kit 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 Aridol Kit approved in United States?

Yes. FDA authorised it on 8 October 1965; FDA authorised it on 22 December 1967; FDA has authorised it.

Who is the marketing authorisation holder for Aridol Kit in United States?

B BRAUN holds the US marketing authorisation.