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FDA NDA · NDA019316

MAGNESIUM SULFATE

magnesium sulfate heptahydrate

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA019316
TYPE
NDA
ORIGINAL APPROVAL
1986-09-08
LATEST ACTION
2018-03-05
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MAGNESIUM SULFATE · ReferencePrescription
MAGNESIUM SULFATE 10GM/20ML (500MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
MAGNESIUM SULFATE · ReferencePrescription
MAGNESIUM SULFATE 5GM/10ML (500MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
MAGNESIUM SULFATE · ReferencePrescription
MAGNESIUM SULFATE 25GM/50ML (500MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
MAGNESIUM SULFATE · ReferencePrescription
MAGNESIUM SULFATE 1GM/2ML (500MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS

Approval history

2018-03-05Labeling · Supplement 24 · standard — Label ↗AP
2016-02-29Manufacturing (CMC) · Supplement 20 · standardAP
2016-01-29Manufacturing (CMC) · Supplement 23 · standardAP
2015-06-19Manufacturing (CMC) · Supplement 22 · standardAP
2013-05-29Labeling · Supplement 18 · unknown — Label ↗AP
2006-12-05Labeling · Supplement 11 · standard — Letter ↗AP
2000-03-01Manufacturing (CMC) · Supplement 4 · standardAP
1998-10-28Labeling · Supplement 8 · standardAP
1996-02-07Manufacturing (CMC) · Supplement 7 · standardAP
1995-02-28Manufacturing (CMC) · Supplement 6 · standardAP
1994-12-12Manufacturing (CMC) · Supplement 5 · standardAP
1991-09-16Labeling · Supplement 3AP
1987-11-13Manufacturing (CMC) · Supplement 2 · standardAP
1987-06-19Manufacturing (CMC) · Supplement 1 · standardAP
1986-09-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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