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FDA ANDA · ANDA207349
MAGNESIUM SULFATE IN DEXTROSE
magnesium sulfate
Sponsor: HQ SPCLT PHARMA
APPLICATION
ANDA207349
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-02
LATEST ACTION
2019-11-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 1GM/100ML · INJECTABLE · INJECTION
Approval history
2019-11-27Labeling · Supplement 7 · standardAP
2019-11-27Labeling · Supplement 5 · standardAP
2016-11-25Manufacturing (CMC) · Supplement 1 · unknownAP
2016-03-02UNKNOWN · 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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