Orange Book product · Brand (NDA)
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
MAGNESIUM SULFATE
At a glance
Jul 11, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 11, 1995
31 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
MAGNESIUM SULFATE
Strength
2GM/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020488
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2007MAGNESIUM SULFATE IN PLASTIC CONTAINERBrand (NDA)
NDA 020309 · HOSPIRA
- 1986MAGNESIUM SULFATEBrand (NDA)
NDA 019316 · FRESENIUS KABI USA
- 2026MAGNESIUM SULFATEGeneric (ANDA)
ANDA 211966 · BAXTER HLTHCARE CORP
- 2025MAGNESIUM SULFATEGeneric (ANDA)
ANDA 219777 · ASPIRO
- 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
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.
