FDA — authorised 8 June 1964
- Marketing authorisation holder: BAXTER HLTHCARE
- Status: approved
🇺🇸 Aridol Kit in United States
FDA authorised Aridol Kit on 8 June 1964
Marketing authorisations
FDA — authorised 8 October 1965
- Application: NDA016080
- Marketing authorisation holder: B BRAUN
- Local brand name: MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 August 1971
- Application: ANDA080224
- Marketing authorisation holder: HOSPIRA
- Local brand name: SORBITOL-MANNITOL
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 10 February 1978
- Application: NDA016772
- Marketing authorisation holder: B BRAUN
- Local brand name: RESECTISOL IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 22 February 1980
- Application: NDA018316
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: SORBITOL-MANNITOL IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 8 January 1987
- Application: NDA019603
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: MANNITOL 10% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 July 1993
- Application: NDA020006
- Marketing authorisation holder: B BRAUN
- Local brand name: MANNITOL 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 October 2010
- Application: NDA022368
- Marketing authorisation holder: PHARMAXIS EUROPE
- Local brand name: ARIDOL KIT
- Indication: POWDER — INHALATION
- Status: approved
Aridol Kit in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Aridol Kit approved in United States?
Yes. FDA authorised it on 8 June 1964; FDA authorised it on 8 October 1965; FDA authorised it on 20 August 1971.
Who is the marketing authorisation holder for Aridol Kit in United States?
BAXTER HLTHCARE holds the US marketing authorisation.