FDA — authorised 12 August 1970
- Application: NDA016733
- Marketing authorisation holder: B BRAUN
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
🇺🇸 Sodium Chloride in United States
FDA authorised Sodium Chloride on 12 August 1970
Marketing authorisations
FDA — authorised 9 December 1970
- Application: NDA016677
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 24 February 1972
- Application: NDA016366
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 December 1974
- Application: NDA017427
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 22 February 1980
- Application: NDA018314
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 30 May 1980
- Application: NDA017867
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 29 October 1982
- Application: NDA018803
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 13 July 1984
- Application: NDA019217
- Marketing authorisation holder: ICU MEDICAL INC
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 10 January 1985
- Application: ANDA088912
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 15 July 1985
- Application: NDA019465
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 17 September 1985
- Application: NDA019480
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 March 1988
- Application: NDA019635
- Marketing authorisation holder: B BRAUN
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 December 1992
- Application: NDA020178
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 27 October 2004
- Application: ANDA076316
- Marketing authorisation holder: GVS TM
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 July 2006
- Application: NDA021569
- Marketing authorisation holder: LIEBEL-FLARSHEIM
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 August 2006
- Application: ANDA077407
- Marketing authorisation holder: TARO
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 18 May 2016
- Application: ANDA203352
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 25 May 2017
- Application: ANDA207956
- Marketing authorisation holder: LABORATORIOS GRIFOLS
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 September 2017
- Application: ANDA207310
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 June 2024
- Application: ANDA213688
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA
- Application: NDA018502
- Marketing authorisation holder: MILES
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA019218
- Marketing authorisation holder: ABBOTT
- Local brand name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INJECTION
- Status: approved
Sodium Chloride 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 Sodium Chloride approved in United States?
Yes. FDA authorised it on 12 August 1970; FDA authorised it on 9 December 1970; FDA authorised it on 24 February 1972.
Who is the marketing authorisation holder for Sodium Chloride in United States?
B BRAUN holds the US marketing authorisation.