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FDA NDA · NDA020488

MAGNESIUM SULFATE IN DEXTROSE

Sponsor: HOSPIRA

APPLICATION
NDA020488
TYPE
NDA
ORIGINAL APPROVAL
1995-07-11
LATEST ACTION
2019-04-16
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
MAGNESIUM SULFATE 1GM/100ML · INJECTABLE · INJECTION
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
MAGNESIUM SULFATE 2GM/100ML · INJECTABLE · INJECTION

Approval history

2019-04-16Labeling · Supplement 24 · standard — Letter ↗AP
2015-07-14Manufacturing (CMC) · Supplement 22 · standardAP
2014-11-26Manufacturing (CMC) · Supplement 21 · standardAP
2013-05-29Labeling · Supplement 19 · standard — Letter ↗AP
2002-11-06Manufacturing (CMC) · Supplement 4 · standardAP
1998-10-28Labeling · Supplement 3 · standardAP
1997-07-14Manufacturing (CMC) · Supplement 2 · standardAP
1997-07-14Manufacturing (CMC) · Supplement 1 · standardAP
1995-07-11Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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