FDA — authorised 7 October 1971
- Application: NDA017038
- Marketing authorisation holder: B BRAUN
- Local brand name: SODIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Plegisol In Plastic Container in United States
FDA authorised Plegisol In Plastic Container on 7 October 1971
Marketing authorisations
FDA — authorised 8 October 1971
- Application: NDA017013
- Marketing authorisation holder: ABBOTT
- Local brand name: SODIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 March 1975
- Application: NDA017670
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 4 April 1979
- Application: NDA018090
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 June 1979
- Application: NDA018184
- Marketing authorisation holder: B BRAUN
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 May 1980
- Application: NDA017864
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 5 August 1980
- Application: NDA018380
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 26 February 1982
- Application: NDA018608
- Marketing authorisation holder: HOSPIRA
- Local brand name: PLEGISOL IN PLASTIC CONTAINER
- Indication: SOLUTION — PERFUSION, CARDIAC
- Status: approved
FDA — authorised 1 November 1983
- Application: NDA019022
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 1984
- Application: NDA018494
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 13 July 1984
- Application: NDA019217
- Marketing authorisation holder: ICU MEDICAL INC
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 20 July 1984
- Application: NDA018897
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM CHLORIDE 14.6%
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 17 May 1985
- Application: NDA019319
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER
- Indication: SOLUTION FOR SLUSH — IRRIGATION
- Status: approved
FDA — authorised 9 March 1988
- Application: NDA019635
- Marketing authorisation holder: B BRAUN
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 June 1988
- Application: NDA019759
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 September 1992
- Application: NDA019912
- Marketing authorisation holder: BLAIREX
- Local brand name: BRONCHO SALINE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 18 February 1994
- Application: NDA020178
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 February 1996
- Application: NDA018883
- Marketing authorisation holder: FRESENIUS MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 24 September 2013
- Application: ANDA201833
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 13 March 2019
- Application: ANDA209476
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 April 2021
- Application: ANDA212070
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SODIUM CHLORIDE 14.6%
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 29 June 2022
- Application: ANDA215370
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA
- Application: NDA018497
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA
- Application: NDA018247
- Marketing authorisation holder: MILES
- Local brand name: SODIUM CHLORIDE IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA
- Application: NDA018503
- Marketing authorisation holder: MILES
- Local brand name: SODIUM CHLORIDE 0.45% 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 Metabolic approved in United States
Frequently asked questions
Is Plegisol In Plastic Container approved in United States?
Yes. FDA authorised it on 7 October 1971; FDA authorised it on 8 October 1971; FDA authorised it on 10 March 1975.
Who is the marketing authorisation holder for Plegisol In Plastic Container in United States?
B BRAUN holds the US marketing authorisation.