FDA — authorised 2 February 1979
- Application: NDA018037
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Dextrose 5% in United States
FDA authorised Dextrose 5% on 2 February 1979
Marketing authorisations
FDA — authorised 2 February 1979
- Application: NDA018008
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 September 1980
- Application: NDA018268
- Marketing authorisation holder: B BRAUN
- Local brand name: DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 March 1982
- Application: NDA018629
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Dextrose 5% 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 Dextrose 5% approved in United States?
Yes. FDA authorised it on 2 February 1979; FDA authorised it on 2 February 1979; FDA authorised it on 5 September 1980.
Who is the marketing authorisation holder for Dextrose 5% in United States?
BAXTER HLTHCARE holds the US marketing authorisation.