FDA — authorised 13 August 1975
- Marketing authorisation holder: HOSPIRA
- Status: approved
🇺🇸 Plegisol In Plastic Container in United States
FDA authorised Plegisol In Plastic Container on 13 August 1975
Marketing authorisations
FDA — authorised 13 August 1975
- Application: NDA017586
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: NORMOSOL-R IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 February 1979
- Application: NDA017378
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 August 1980
- Application: NDA018252
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE S IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 August 1980
- Application: NDA018406
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: PHYSIOSOL 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 2 April 1984
- Application: NDA019006
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE S PH 7.4 IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 June 1984
- Application: NDA019024
- Marketing authorisation holder: B BRAUN
- Local brand name: PHYSIOLYTE IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 29 September 1989
- Application: NDA019696
- Marketing authorisation holder: B BRAUN
- Local brand name: ISOLYTE S PH 7.4 IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 February 1996
- Application: NDA018883
- Marketing authorisation holder: FRESENIUS MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 20 December 2002
- Application: NDA021321
- Marketing authorisation holder: VANTIVE US HLTHCARE
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA — authorised 26 July 2006
- Application: NDA021910
- Marketing authorisation holder: DIALYSIS SUPS
- Local brand name: NORMOCARB HF 25
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 8 June 2022
- Application: ANDA215371
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 2022
- Application: ANDA215370
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5
- 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 Neuroscience approved in United States
Frequently asked questions
Is Plegisol In Plastic Container approved in United States?
Yes. FDA authorised it on 13 August 1975; FDA authorised it on 13 August 1975; FDA authorised it on 2 February 1979.
Who is the marketing authorisation holder for Plegisol In Plastic Container in United States?
HOSPIRA holds the US marketing authorisation.