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FDA ANDA · ANDA211190

DEXTROSE AND SODIUM CHLORIDE

dextrose monohydrate, sodium chloride

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA211190
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-20
LATEST ACTION
2019-12-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 2.5GM/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION

Approval history

2019-12-20UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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