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FDA ANDA · ANDA206485

MAGNESIUM SULFATE

magnesium sulfate heptahydrate

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA206485
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-15
LATEST ACTION
2016-03-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MAGNESIUM SULFATE IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 4GM/100ML (40MG/ML) · INJECTABLE · INJECTION
MAGNESIUM SULFATE IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 20GM/500ML (40MG/ML) · INJECTABLE · INJECTION
MAGNESIUM SULFATE IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 4GM/50ML (80MG/ML) · INJECTABLE · INJECTION
MAGNESIUM SULFATE IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 40GM/1000ML (40MG/ML) · INJECTABLE · INJECTION
MAGNESIUM SULFATE IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 2GM/50ML (40MG/ML) · INJECTABLE · INJECTION

Approval history

2016-03-15UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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