Orange Book product · Generic (ANDA)
MAGNESIUM SULFATE
MAGNESIUM SULFATE
At a glance
May 28, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 2025
1 yr 1 mo ago
Exclusivity ends · CGT
FDA marketing exclusivity
Feb 01, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
MAGNESIUM SULFATE
Strength
1GM/2ML (500MG/ML)
Dosage form
SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS
TE code
AP
Application
ANDA 219777
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MAGNESIUM SULFATE
- 2007MAGNESIUM SULFATE IN PLASTIC CONTAINERBrand (NDA)
NDA 020309 · HOSPIRA
- 1995MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 020488 · HOSPIRA
- 1986MAGNESIUM SULFATEBrand (NDA)
NDA 019316 · FRESENIUS KABI USA
- 2026MAGNESIUM SULFATEGeneric (ANDA)
ANDA 211966 · BAXTER HLTHCARE CORP
- 2023MAGNESIUM SULFATE IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 216597 · AMNEAL
- 2021MAGNESIUM SULFATE IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 209642 · MILLA PHARMS
- 2021MAGNESIUM SULFATEGeneric (ANDA)
ANDA 207967 · B BRAUN MEDICAL
- 2020MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 207966 · B BRAUN MEDICAL
- 2020MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 211965 · BAXTER HLTHCARE CORP
- 2020MAGNESIUM SULFATE IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 213917 · GLAND
- 2018MAGNESIUM SULFATE IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 209911 · MYLAN LABS LTD
- 2018MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 209932 · PHARMOBEDIENT
Marketing exclusivity (1)
- CGTFDA marketing exclusivity
Feb 01, 2026
5 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
