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
🇺🇸 Bacteriostatic Water For Injection In Plastic Container in United States
FDA authorised Bacteriostatic Water For Injection In Plastic Container on 18 February 1980
Marketing authorisations
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 27 October 1982
- Application: NDA018802
- Marketing authorisation holder: HOSPIRA
- Local brand name: BACTERIOSTATIC 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 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 31 January 2023
- Application: ANDA212735
- Marketing authorisation holder: HIKMA
- 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
FDA
- Application: ANDA089100
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
- Indication: LIQUID — N/A
- Status: approved
FDA
- Application: ANDA089099
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
- Indication: LIQUID — N/A
- Status: approved
FDA
- Status: approved
Pricing & reimbursement
- annual_list: USD 80000.00 per year
Bacteriostatic Water For Injection 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 Bacteriostatic Water For Injection In Plastic Container approved in United States?
Yes. FDA authorised it on 18 February 1980; FDA authorised it on 27 October 1982; FDA authorised it on 27 October 1982.
Who is the marketing authorisation holder for Bacteriostatic Water For Injection In Plastic Container in United States?
OTSUKA ICU MEDCL holds the US marketing authorisation.
What does Bacteriostatic Water For Injection In Plastic Container cost in United States?
annual_list: USD 80000.00 per year. Final patient cost depends on reimbursement and any patient access scheme.