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FDA ANDA · ANDA211966
MAGNESIUM SULFATE
magnesium sulfate heptahydrate
Sponsor: BAXTER HLTHCARE CORP
APPLICATION
ANDA211966
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-01
LATEST ACTION
2026-01-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MAGNESIUM SULFATEPrescription
MAGNESIUM SULFATE 3GM/100ML (30MG/ML) · INJECTABLE · INJECTION
MAGNESIUM SULFATE IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 4GM/50ML (80MG/ML) · INJECTABLE · INJECTION
MAGNESIUM SULFATE IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 4GM/100ML (40MG/ML) · INJECTABLE · INJECTION
MAGNESIUM SULFATE IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 2GM/50ML (40MG/ML) · INJECTABLE · INJECTION
Approval history
2026-01-08Manufacturing (CMC) · Supplement 11 · unknownAP
2022-05-10Manufacturing (CMC) · Supplement 1 · standardAP
2020-06-01UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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