APPLICATION
ANDA207449
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-21
LATEST ACTION
2026-07-14
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 5% IN PLASTIC CONTAINERPrescription
DEXTROSE 50MG/ML · INJECTABLE · INJECTION
Approval history
2026-07-14Labeling · Supplement 30 · standardAP
2022-07-20Manufacturing (CMC) · Supplement 19 · unknownAP
2020-11-20Manufacturing (CMC) · Supplement 14 · unknownAP
2018-06-26Labeling · Supplement 3 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.