FDA — authorised 22 March 1971
- Application: NDA016679
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Plegisol In Plastic Container in United States
FDA authorised Plegisol In Plastic Container on 22 March 1971
Marketing authorisations
FDA — authorised 22 March 1971
- Application: NDA016682
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 August 1975
- Application: NDA017608
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 January 1976
- Application: NDA017641
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 February 1978
- Application: NDA018023
- Marketing authorisation holder: B BRAUN
- Local brand name: LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 February 1979
- Application: NDA017438
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: PLASMA-LYTE R IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 February 1979
- Application: NDA017390
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 August 1979
- Application: NDA018156
- Marketing authorisation holder: B BRAUN
- Local brand name: RINGER'S IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 28 August 1979
- Application: NDA018256
- Marketing authorisation holder: B BRAUN
- Local brand name: DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 January 1980
- Application: NDA018254
- Marketing authorisation holder: HOSPIRA
- Local brand name: DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 October 1980
- Application: NDA018269
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 October 1980
- Application: NDA018271
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 February 1982
- Application: NDA018494
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 19 February 1982
- Application: NDA018495
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: RINGER'S IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 9 November 1982
- Application: NDA018721
- Marketing authorisation holder: B BRAUN
- Local brand name: RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 November 1982
- Application: NDA018725
- Marketing authorisation holder: B BRAUN
- Local brand name: ACETATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 December 1982
- Application: NDA018681
- Marketing authorisation holder: B BRAUN
- Local brand name: LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 26 August 1983
- Application: NDA018807
- Marketing authorisation holder: B BRAUN
- Local brand name: DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER
- Indication: SOLUTION — INTRAPERITONEAL
- Status: approved
FDA — authorised 31 October 1983
- Application: NDA018899
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE E IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 April 1985
- Application: NDA019367
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 January 1986
- Application: NDA019416
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 24 February 1988
- Application: NDA019634
- Marketing authorisation holder: B BRAUN
- Local brand name: DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 February 1988
- Application: NDA019632
- Marketing authorisation holder: B BRAUN
- Local brand name: LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 October 1988
- Application: NDA019685
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 September 1989
- Application: NDA019718
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE E IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 January 1991
- Application: NDA018921
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 17 April 1992
- Application: NDA020000
- Marketing authorisation holder: B BRAUN
- Local brand name: DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 April 1992
- Application: NDA020002
- Marketing authorisation holder: B BRAUN
- Local brand name: RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 August 1992
- Application: NDA020171
- Marketing authorisation holder: FRESENIUS MEDCL
- Local brand name: DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
- Indication: SOLUTION — INTRAPERITONEAL
- Status: approved
FDA — authorised 22 February 1996
- Application: NDA018883
- Marketing authorisation holder: FRESENIUS MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 January 2000
- Application: NDA021117
- Marketing authorisation holder: HOSPIRA
- Local brand name: CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 September 2006
- Application: ANDA075503
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: BALANCED SALT
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 25 October 2006
- Application: NDA021703
- Marketing authorisation holder: VANTIVE US HLTHCARE
- Local brand name: PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 July 2008
- Application: NDA022193
- Marketing authorisation holder: ALCON PHARMS LTD
- Local brand name: NAVSTEL
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 27 July 2017
- Application: ANDA209088
- Marketing authorisation holder: AM REGENT
- Local brand name: CALCIUM CHLORIDE 10%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 January 2019
- Application: ANDA209338
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 May 2019
- Application: ANDA211553
- Marketing authorisation holder: MEDEFIL INC
- Status: approved
FDA — authorised 9 November 2021
- Application: ANDA211428
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 March 2022
- Application: ANDA210332
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DEXTROSE 5% AND LACTATED RINGER'S
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 November 2024
- Application: ANDA219342
- Marketing authorisation holder: EXTROVIS
- Local brand name: CALCIUM CHLORIDE 10%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 September 2025
- Application: ANDA217463
- Marketing authorisation holder: SQUARE PHARMS PLC
- Local brand name: CALCIUM CHLORIDE 10%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA018417
- Marketing authorisation holder: MILES
- Local brand name: LACTATED RINGER'S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
Plegisol 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 Dermatology approved in United States
Frequently asked questions
Is Plegisol In Plastic Container approved in United States?
Yes. FDA authorised it on 22 March 1971; FDA authorised it on 22 March 1971; FDA authorised it on 13 August 1975.
Who is the marketing authorisation holder for Plegisol In Plastic Container in United States?
BAXTER HLTHCARE holds the US marketing authorisation.