FDA — authorised 24 June 1994
- Application: NDA020309
- Marketing authorisation holder: HOSPIRA
- Local brand name: MAGNESIUM SULFATE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Magnesium Sulfate in United States
FDA authorised Magnesium Sulfate on 24 June 1994
Marketing authorisations
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 15 March 2016
- Application: ANDA206485
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MAGNESIUM SULFATE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 December 2017
- Application: ANDA207350
- Marketing authorisation holder: HQ SPCLT PHARMA
- Local brand name: MAGNESIUM SULFATE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 September 2018
- Application: ANDA209911
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: MAGNESIUM SULFATE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 July 2020
- Application: ANDA213917
- Marketing authorisation holder: GLAND
- Local brand name: MAGNESIUM SULFATE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- 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 8 November 2021
- Application: ANDA209642
- Marketing authorisation holder: MILLA PHARMS
- Local brand name: MAGNESIUM SULFATE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 February 2023
- Application: ANDA216597
- Marketing authorisation holder: AMNEAL
- Local brand name: MAGNESIUM SULFATE IN PLASTIC CONTAINER
- 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
FDA
- Status: approved
Magnesium Sulfate 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 Magnesium Sulfate approved in United States?
Yes. FDA authorised it on 24 June 1994; FDA authorised it on 25 April 2000; FDA authorised it on 18 December 2014.
Who is the marketing authorisation holder for Magnesium Sulfate in United States?
HOSPIRA holds the US marketing authorisation.