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FDA NDA · NDA019445

DEXTROSE

dextrose monohydrate

Sponsor: HOSPIRA

APPLICATION
NDA019445
TYPE
NDA
ORIGINAL APPROVAL
1986-06-03
LATEST ACTION
2025-07-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEXTROSE 50% · ReferencePrescription
DEXTROSE 500MG/ML · INJECTABLE · INJECTION
DEXTROSE 25% · ReferencePrescription
DEXTROSE 250MG/ML · INJECTABLE · INJECTION

Approval history

2025-07-25Labeling · Supplement 49 · standard — Letter ↗AP
2025-07-25Labeling · Supplement 43 · standard — Letter ↗AP
1998-11-23Efficacy · Supplement 6 · standardAP
1998-11-23Efficacy · Supplement 4 · standardAP
1986-06-03Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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