APPLICATION
NDA016694
TYPE
NDA
ORIGINAL APPROVAL
1971-01-25
LATEST ACTION
2026-06-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 10% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 10GM/100ML · INJECTABLE · INJECTION
Approval history
2016-01-15Manufacturing (CMC) · Supplement 123 · standardAP
2014-05-23Manufacturing (CMC) · Supplement 120 · standardAP
2006-07-10Labeling · Supplement 113AP
2005-02-04Labeling · Supplement 108AP
2003-05-15Labeling · Supplement 107AP
2001-08-29Manufacturing (CMC) · Supplement 105 · standardAP
2001-08-14Manufacturing (CMC) · Supplement 104 · standardAP
2001-08-14Labeling · Supplement 103AP
2000-01-28Manufacturing (CMC) · Supplement 102 · standardAP
1999-09-15Labeling · Supplement 98AP
1999-07-30Manufacturing (CMC) · Supplement 101 · standardAP
1998-05-27Manufacturing (CMC) · Supplement 100 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 99 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 96 · standardAP
1994-03-17Manufacturing (CMC) · Supplement 95 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 97 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 93 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 92 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 90 · standardAP
1990-07-30Manufacturing (CMC) · Supplement 91 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 89 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 88 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 87 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 86 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 83 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 73 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 74 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 81 · standardAP
1985-04-10Labeling · Supplement 82AP
1985-01-24Manufacturing (CMC) · Supplement 71 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 56 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 80 · standardAP
1984-06-07Manufacturing (CMC) · Supplement 76 · standardAP
1984-06-07Labeling · Supplement 77AP
1984-04-13Labeling · Supplement 79AP
1984-03-16Manufacturing (CMC) · Supplement 72 · 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.