FDA — authorised 22 December 1967
- Application: NDA016269
- Marketing authorisation holder: HOSPIRA
- Local brand name: MANNITOL 25%
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Aridol Kit in United States
FDA authorised Aridol Kit on 22 December 1967
Marketing authorisations
FDA — authorised 11 August 1972
- Application: ANDA080677
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MANNITOL 25%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 August 1975
- Application: ANDA083051
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: MANNITOL 25%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 June 1980
- Application: ANDA086754
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: MANNITOL 25%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 January 1982
- Application: ANDA087409
- Marketing authorisation holder: LUITPOLD
- Local brand name: MANNITOL 25%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 May 1987
- Application: ANDA089240
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MANNITOL 25%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 May 1987
- Application: ANDA089239
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MANNITOL 25%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA005620
- Marketing authorisation holder: MERCK
- Local brand name: MANNITOL 25%
- Indication: INJECTABLE — INJECTION
- 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.
Frequently asked questions
Is Aridol Kit approved in United States?
Yes. FDA authorised it on 22 December 1967; FDA authorised it on 11 August 1972; FDA authorised it on 29 August 1975.
Who is the marketing authorisation holder for Aridol Kit in United States?
HOSPIRA holds the US marketing authorisation.