APPLICATION
NDA016367
TYPE
NDA
ORIGINAL APPROVAL
1971-02-12
LATEST ACTION
2025-06-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 50MG/ML · INJECTABLE · INJECTION
Approval history
2016-02-23Manufacturing (CMC) · Supplement 220 · standardAP
2013-09-05Manufacturing (CMC) · Supplement 218 · standardAP
2002-11-08Manufacturing (CMC) · Supplement 174 · standardAP
2002-04-03Manufacturing (CMC) · Supplement 172 · standardAP
2002-04-03Manufacturing (CMC) · Supplement 173 · standardAP
2000-03-06Labeling · Supplement 170 · standardAP
2000-03-03Manufacturing (CMC) · Supplement 171 · standardAP
1999-06-04Manufacturing (CMC) · Supplement 169 · standardAP
1998-10-29Manufacturing (CMC) · Supplement 168 · standardAP
1997-08-21Manufacturing (CMC) · Supplement 167 · standardAP
1997-08-20Labeling · Supplement 165 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 166 · standardAP
1997-03-28Manufacturing (CMC) · Supplement 164 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 160 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 159 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 163 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 162 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 161 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 157 · standardAP
1994-05-24Labeling · Supplement 156 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 152 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 151 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 153 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 148 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 149 · standardAP
1989-06-14Manufacturing (CMC) · Supplement 147 · standardAP
1988-10-17Manufacturing (CMC) · Supplement 145 · standardAP
1988-08-31Manufacturing (CMC) · Supplement 107 · standardAP
1988-08-08Manufacturing (CMC) · Supplement 146 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 142 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 141 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 140 · standardAP
1986-02-21Manufacturing (CMC) · Supplement 139 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 138 · standardAP
1985-11-29Labeling · Supplement 111AP
1985-11-29Manufacturing (CMC) · Supplement 110 · standardAP
1985-11-07Labeling · Supplement 133AP
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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