FDA — authorised 6 October 1981
- Application: NDA018336
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: TIS-U-SOL IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
🇺🇸 Magnesium Sulfate low dose in United States
FDA authorised Magnesium Sulfate low dose on 6 October 1981
Marketing authorisations
FDA — authorised 8 September 1986
- Application: NDA019316
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MAGNESIUM SULFATE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 25 April 2000
- Application: ANDA075151
- Marketing authorisation holder: HOSPIRA
- Local brand name: MAGNESIUM SULFATE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 18 December 2014
- Application: ANDA206039
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: MAGNESIUM SULFATE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 27 December 2016
- Application: NDA204553
- Marketing authorisation holder: GATOR PHARMS
- Local brand name: COLPREP KIT
- Indication: POWDER — ORAL
- Status: approved
FDA — authorised 26 April 2021
- Application: ANDA207967
- Marketing authorisation holder: B BRAUN MEDICAL
- Local brand name: MAGNESIUM SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 June 2023
- Application: NDA215344
- Marketing authorisation holder: AZURITY
- Local brand name: SUFLAVE
- Indication: FOR SOLUTION — ORAL
- Status: approved
Frequently asked questions
Is Magnesium Sulfate low dose approved in United States?
Yes. FDA authorised it on 6 October 1981; FDA authorised it on 8 September 1986; FDA authorised it on 25 April 2000.
Who is the marketing authorisation holder for Magnesium Sulfate low dose in United States?
BAXTER HLTHCARE holds the US marketing authorisation.