APPLICATION
ANDA075151
TYPE
ANDA
ORIGINAL APPROVAL
2000-04-25
LATEST ACTION
2019-11-26
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
MAGNESIUM SULFATEPrescription
MAGNESIUM SULFATE 5GM/10ML (500MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
Approval history
2019-11-26Labeling · Supplement 15 · standardAP
2015-10-26Labeling · Supplement 13 · standardAP
2012-12-17Manufacturing (CMC) · Supplement 11AP
2004-08-23Labeling · Supplement 2AP
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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