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FDA ANDA · ANDA211221

DEXTROSE AND SODIUM CHLORIDE

dextrose monohydrate and sodium chloride

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA211221
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-15
LATEST ACTION
2020-09-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEXTROSE 5% AND SODIUM CHLORIDE 0.225%Prescription
DEXTROSE 5GM/100ML, SODIUM CHLORIDE 225MG/100ML · INJECTABLE · INJECTION

Approval history

2020-09-15UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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