Orange Book product · Brand (NDA)
MAGNESIUM SULFATE IN PLASTIC CONTAINER
MAGNESIUM SULFATE
At a glance
Jan 18, 1995
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 18, 1995
31 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
MAGNESIUM SULFATE
Strength
40GM/1000ML (40MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 020309
Product number
005
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 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
- 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.
