FDA — authorised 10 September 1970
- Application: NDA016734
- Marketing authorisation holder: B BRAUN
- Local brand name: STERILE WATER IN PLASTIC CONTAINER
- Indication: LIQUID — IRRIGATION
- Status: approved
🇺🇸 STERILE WATER IN PLASTIC CONTAINER in United States
FDA authorised STERILE WATER IN PLASTIC CONTAINER on 10 September 1970
Marketing authorisations
FDA — authorised 22 February 1980
- Application: NDA018313
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: STERILE WATER IN PLASTIC CONTAINER
- Indication: LIQUID — IRRIGATION
- Status: approved
FDA — authorised 30 May 1980
- Application: NDA017866
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: STERILE WATER IN PLASTIC CONTAINER
- Indication: LIQUID — IRRIGATION
- Status: approved
FDA — authorised 12 August 2024
- Application: ANDA216123
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: STERILE WATER FOR IRRIGATION
- Indication: LIQUID — IRRIGATION
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA018246
- Marketing authorisation holder: MILES
- Local brand name: STERILE WATER IN PLASTIC CONTAINER
- Indication: LIQUID — IRRIGATION
- Status: approved
STERILE WATER 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 Other approved in United States
Frequently asked questions
Is STERILE WATER IN PLASTIC CONTAINER approved in United States?
Yes. FDA authorised it on 10 September 1970; FDA authorised it on 22 February 1980; FDA authorised it on 30 May 1980.
Who is the marketing authorisation holder for STERILE WATER IN PLASTIC CONTAINER in United States?
B BRAUN holds the US marketing authorisation.