FDA — authorised 29 October 1982
- Application: NDA018800
- Marketing authorisation holder: HOSPIRA
- Local brand name: BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
🇺🇸 Plegisol In Plastic Container in United States
FDA authorised Plegisol In Plastic Container on 29 October 1982
Marketing authorisations
FDA — authorised 28 February 1984
- Application: NDA018494
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 7 February 1985
- Application: ANDA088911
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- 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 29 June 2022
- Application: ANDA215370
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA
- Application: ANDA088909
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — 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.
Frequently asked questions
Is Plegisol In Plastic Container approved in United States?
Yes. FDA authorised it on 29 October 1982; FDA authorised it on 28 February 1984; FDA authorised it on 7 February 1985.
Who is the marketing authorisation holder for Plegisol In Plastic Container in United States?
HOSPIRA holds the US marketing authorisation.