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FDA ANDA · ANDA211965

MAGNESIUM SULFATE IN DEXTROSE

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
ANDA211965
TYPE
ANDA
ORIGINAL APPROVAL
2020-08-11
LATEST ACTION
2022-05-10
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

2022-05-10Manufacturing (CMC) · Supplement 1 · standardAP
2020-08-11UNKNOWN · 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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