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FDA ANDA · ANDA216597
MAGNESIUM SULFATE
magnesium sulfate in water for
Sponsor: AMNEAL
APPLICATION
ANDA216597
TYPE
ANDA
ORIGINAL APPROVAL
2023-02-15
LATEST ACTION
2023-07-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MAGNESIUM SULFATE IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 2GM/50ML (40MG/ML) · INJECTABLE · INJECTION
MAGNESIUM SULFATE IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 4GM/100ML (40MG/ML) · INJECTABLE · INJECTION
Approval history
2023-07-12Labeling · Supplement 1 · standardAP
2023-02-15UNKNOWN · 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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