🇺🇸 Mannitol in United States

FDA authorised Mannitol on 30 July 1964

Marketing authorisations

FDA — authorised 30 July 1964

  • Application: NDA014738
  • Marketing authorisation holder: B BRAUN
  • Local brand name: MANNITOL 20%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 8 October 1965

  • Application: NDA016080
  • Marketing authorisation holder: B BRAUN
  • Local brand name: MANNITOL 20%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 22 December 1967

  • Application: NDA016269
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: MANNITOL 20%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA

  • Status: approved

FDA

  • Application: NDA016472
  • Marketing authorisation holder: MILES
  • Local brand name: MANNITOL 20%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

Pricing & reimbursement

Mannitol in other countries

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

Other Cardiovascular approved in United States

Frequently asked questions

Is Mannitol approved in United States?

Yes. FDA authorised it on 30 July 1964; FDA authorised it on 8 October 1965; FDA authorised it on 22 December 1967.

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

B BRAUN holds the US marketing authorisation.

What does Mannitol cost in United States?

annual_list: USD 0.00 per year. Final patient cost depends on reimbursement and any patient access scheme.