FDA — authorised 8 October 1971
- Application: NDA017013
- Marketing authorisation holder: ABBOTT
- Local brand name: SODIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 MOVICOL in United States
FDA authorised MOVICOL on 8 October 1971
Marketing authorisations
FDA — authorised 8 June 1979
- Application: NDA018184
- Marketing authorisation holder: B BRAUN
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 May 1980
- Application: NDA017864
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 1 November 1983
- Application: NDA019022
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — 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 THERMOJECT KIT FOR CARDIAC OUTPUT USE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 7 August 1985
- Application: NDA018509
- Marketing authorisation holder: MALLINCKRODT INC
- Local brand name: BAROS
- Indication: GRANULE, EFFERVESCENT — ORAL
- Status: approved
FDA — authorised 3 June 1986
- Application: NDA019443
- Marketing authorisation holder: ABBOTT
- Local brand name: SODIUM BICARBONATE IN PLASTIC CONTAINER
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 9 March 1988
- Application: NDA019635
- Marketing authorisation holder: B BRAUN
- Local brand name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 September 1992
- Application: NDA019912
- Marketing authorisation holder: BLAIREX
- Local brand name: BRONCHO SALINE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 9 November 2005
- Application: ANDA077394
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM BICARBONATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 March 2016
- Application: ANDA202981
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM BICARBONATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 March 2017
- Application: ANDA202495
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM BICARBONATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 March 2017
- Application: ANDA202494
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM BICARBONATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 20 June 2019
- Application: ANDA211091
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: SODIUM BICARBONATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 25 August 2025
- Application: ANDA206688
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SODIUM BICARBONATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Status: approved
MOVICOL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is MOVICOL approved in United States?
Yes. FDA authorised it on 8 October 1971; FDA authorised it on 8 June 1979; FDA authorised it on 30 May 1980.
Who is the marketing authorisation holder for MOVICOL in United States?
ABBOTT holds the US marketing authorisation.