FDA — authorised 22 May 1998
- Application: NDA020577
- Marketing authorisation holder: LUKARE MEDICAL LLC
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Magnesium Sulfate In Dextrose 5% In Plastic Container in United States
FDA authorised Magnesium Sulfate In Dextrose 5% In Plastic Container on 22 May 1998
Marketing authorisations
FDA — authorised 2 March 2016
- Application: ANDA207349
- Marketing authorisation holder: HQ SPCLT PHARMA
- Local brand name: MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 March 2016
- Application: ANDA206486
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 March 2016
- Application: ANDA206485
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 5 August 2020
- Application: NDA022372
- Marketing authorisation holder: AZURITY
- Indication: Efficacy
- Status: approved
FDA — authorised 27 October 2020
- Application: ANDA207966
- Marketing authorisation holder: B BRAUN MEDICAL
- Local brand name: MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 June 2024
- Application: ANDA204135
- Marketing authorisation holder: BIONPHARMA
- Status: approved
Magnesium Sulfate In Dextrose 5% 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.
Frequently asked questions
Is Magnesium Sulfate In Dextrose 5% In Plastic Container approved in United States?
Yes. FDA authorised it on 22 May 1998; FDA authorised it on 2 March 2016; FDA authorised it on 7 March 2016.
Who is the marketing authorisation holder for Magnesium Sulfate In Dextrose 5% In Plastic Container in United States?
LUKARE MEDICAL LLC holds the US marketing authorisation.