FDA — authorised 8 December 1970
- Application: NDA016689
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Dextrose 5% in water in United States
FDA authorised Dextrose 5% in water on 8 December 1970
Marketing authorisations
FDA — authorised 9 December 1970
- Application: NDA016678
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 February 1971
- Application: NDA016367
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 March 1971
- Application: NDA016673
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 March 1971
- Application: NDA016683
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 March 1971
- Application: NDA016687
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 December 1973
- Application: NDA016730
- Marketing authorisation holder: B BRAUN
- Local brand name: DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 August 1975
- Application: NDA017606
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 August 1975
- Application: NDA017609
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 August 1975
- Application: NDA017610
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 August 1975
- Application: NDA017607
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 February 1978
- Application: NDA018030
- Marketing authorisation holder: B BRAUN
- Local brand name: DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 April 1978
- Application: NDA017995
- Marketing authorisation holder: B BRAUN
- Local brand name: DEXTROSE 60%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 February 1979
- Application: NDA017385
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 February 1979
- Application: NDA017484
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 June 1979
- Application: NDA018229
- Marketing authorisation holder: B BRAUN
- Local brand name: DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 August 1979
- Application: NDA018080
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 10% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 August 1979
- Application: NDA017521
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 50% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 April 1980
- Application: NDA018358
- Marketing authorisation holder: B BRAUN
- Local brand name: DEXTROSE 2.5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 May 1980
- Application: NDA018362
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 May 1980
- Application: NDA018365
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 May 1980
- Application: NDA018371
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 July 1980
- Application: NDA018376
- Marketing authorisation holder: B BRAUN
- Local brand name: DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 October 1980
- Application: NDA018270
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 March 1982
- Application: NDA018563
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 50% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 March 1982
- Application: NDA018561
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 70% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 March 1982
- Application: NDA018562
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 40% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 March 1982
- Application: NDA018564
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 20% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 1983
- Application: NDA018840
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 5% AND ELECTROLYTE NO. 75 IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 December 1984
- Application: NDA019025
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 January 1985
- Application: NDA019346
- Marketing authorisation holder: HOSPIRA
- Local brand name: DEXTROSE 60% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 January 1985
- Application: NDA019345
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 30% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 July 1985
- Application: NDA019466
- Marketing authorisation holder: HOSPIRA
- Local brand name: DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 January 1986
- Application: NDA018876
- Marketing authorisation holder: ICU MEDICAL INC
- Local brand name: POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 June 1986
- Application: NDA019445
- Marketing authorisation holder: HOSPIRA
- Local brand name: DEXTROSE 25%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 March 1988
- Application: NDA019691
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 December 1989
- Application: NDA019893
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 70% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 July 1991
- Application: NDA020047
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DEXTROSE 50% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 June 1993
- Application: NDA019844
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 August 1993
- Application: NDA019843
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 October 2016
- Application: ANDA207449
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 July 2018
- Application: ANDA209448
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DEXTROSE 10% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 March 2021
- Application: ANDA213523
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Dextrose 5% in water 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% in water approved in United States?
Yes. FDA authorised it on 8 December 1970; FDA authorised it on 9 December 1970; FDA authorised it on 12 February 1971.
Who is the marketing authorisation holder for Dextrose 5% in water in United States?
BAXTER HLTHCARE holds the US marketing authorisation.