APPLICATION
NDA016673
TYPE
NDA
ORIGINAL APPROVAL
1971-03-04
LATEST ACTION
2026-06-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 50MG/ML · INJECTABLE · INJECTION
DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML · INJECTABLE · INJECTION
Approval history
2016-07-14Manufacturing (CMC) · Supplement 152 · standardAP
2016-01-15Manufacturing (CMC) · Supplement 151 · standardAP
2015-09-16Manufacturing (CMC) · Supplement 150 · standardAP
2014-05-23Manufacturing (CMC) · Supplement 148 · standardAP
2006-07-10Labeling · Supplement 140AP
2005-02-04Labeling · Supplement 135AP
2003-05-15Labeling · Supplement 129AP
2001-08-29Manufacturing (CMC) · Supplement 127 · standardAP
2000-01-28Manufacturing (CMC) · Supplement 126 · standardAP
1999-09-15Labeling · Supplement 122AP
1997-12-29Manufacturing (CMC) · Supplement 125 · standardAP
1997-06-10Manufacturing (CMC) · Supplement 123 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 124 · standardAP
1996-11-14Manufacturing (CMC) · Supplement 120 · standardAP
1996-10-11Manufacturing (CMC) · Supplement 121 · standardAP
1995-09-27Manufacturing (CMC) · Supplement 119 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 117 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 118 · standardAP
1993-06-01Manufacturing (CMC) · Supplement 112 · standardAP
1993-01-06Manufacturing (CMC) · Supplement 116 · standardAP
1992-11-23Manufacturing (CMC) · Supplement 111 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 110 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 107 · standardAP
1990-07-30Manufacturing (CMC) · Supplement 109 · standardAP
1990-03-23Manufacturing (CMC) · Supplement 108 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 106 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 105 · standardAP
1989-01-10Manufacturing (CMC) · Supplement 103 · standardAP
1988-06-14Manufacturing (CMC) · Supplement 104 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 101 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 100 · standardAP
1987-04-27Manufacturing (CMC) · Supplement 102 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 97 · standardAP
1985-10-30Labeling · Supplement 90AP
1985-10-30Manufacturing (CMC) · Supplement 89 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 84 · 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.
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