FDA — authorised 8 May 1986
- Application: NDA019513
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER in United States
FDA authorised IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER on 8 May 1986
Marketing authorisations
FDA
- Status: approved
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER approved in United States?
Yes. FDA authorised it on 8 May 1986; FDA has authorised it.
Who is the marketing authorisation holder for IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER in United States?
OTSUKA ICU MEDCL holds the US marketing authorisation.