FDA — authorised 31 December 1974
- Application: NDA017428
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: STERILE WATER
- Indication: LIQUID — IRRIGATION
- Status: approved
🇺🇸 Sterile Water in United States
FDA authorised Sterile Water on 31 December 1974
Marketing authorisations
FDA — authorised 18 February 1980
- Application: NDA018233
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 30 June 1982
- Application: NDA018632
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 27 October 1982
- Application: NDA018801
- Marketing authorisation holder: HOSPIRA
- Local brand name: STERILE WATER FOR INJECTION
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 16 January 1984
- Application: ANDA088400
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 2 March 1984
- Application: NDA019077
- Marketing authorisation holder: B BRAUN
- Local brand name: STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 29 February 1988
- Application: NDA019633
- Marketing authorisation holder: B BRAUN
- Local brand name: STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 26 December 1989
- Application: NDA019869
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 11 August 2006
- Application: ANDA077393
- Marketing authorisation holder: TARO
- Local brand name: STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 2 September 2015
- Application: ANDA206369
- Marketing authorisation holder: HIKMA
- Local brand name: STERILE WATER FOR INJECTION
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 24 November 2017
- Application: ANDA209689
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: STERILE WATER FOR INJECTION
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 2 December 2019
- Application: ANDA211188
- Marketing authorisation holder: MEDEFIL INC
- Local brand name: STERILE WATER FOR INJECTION
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 10 February 2021
- Application: ANDA211222
- Marketing authorisation holder: NEPHRON
- Local brand name: STERILE WATER FOR INJECTION
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 31 January 2023
- Application: ANDA212735
- Marketing authorisation holder: HIKMA
- Local brand name: STERILE WATER FOR INJECTION
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 11 July 2023
- Application: ANDA217536
- Marketing authorisation holder: NEXUS
- Local brand name: STERILE WATER FOR INJECTION
- Indication: LIQUID — N/A
- Status: approved
FDA — authorised 29 August 2023
- Application: ANDA217341
- Marketing authorisation holder: AM REGENT
- Local brand name: STERILE WATER FOR INJECTION
- Indication: LIQUID — N/A
- Status: approved
Sterile 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 Sterile Water approved in United States?
Yes. FDA authorised it on 31 December 1974; FDA authorised it on 18 February 1980; FDA authorised it on 30 June 1982.
Who is the marketing authorisation holder for Sterile Water in United States?
BAXTER HLTHCARE holds the US marketing authorisation.