APPLICATION
NDA016730
TYPE
NDA
ORIGINAL APPROVAL
1973-12-21
LATEST ACTION
2026-05-12
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
2014-09-29Manufacturing (CMC) · Supplement 52 · standardAP
2006-10-19Labeling · Supplement 50AP
2004-08-06Labeling · Supplement 48AP
1997-06-23Manufacturing (CMC) · Supplement 46 · standardAP
1995-08-08Manufacturing (CMC) · Supplement 45 · standardAP
1991-12-31Manufacturing (CMC) · Supplement 43 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 42 · standardAP
1989-03-09Manufacturing (CMC) · Supplement 39 · standardAP
1986-02-18Manufacturing (CMC) · Supplement 27 · standardAP
1986-01-30Manufacturing (CMC) · Supplement 38 · standardAP
1985-09-16Manufacturing (CMC) · Supplement 35 · standardAP
1985-06-24Labeling · Supplement 36AP
1985-06-21Manufacturing (CMC) · Supplement 26 · standardAP
1985-05-17Manufacturing (CMC) · Supplement 28 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 32 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 33 · standardAP
1984-10-16Labeling · Supplement 34AP
1984-04-09Manufacturing (CMC) · Supplement 31 · standardAP
1983-09-30Manufacturing (CMC) · Supplement 29 · standardAP
1983-01-24Labeling · Supplement 20AP
1982-11-05Manufacturing (CMC) · Supplement 24 · standardAP
1982-06-28Manufacturing (CMC) · Supplement 22 · standardAP
1982-06-28Labeling · Supplement 23AP
1981-10-26Manufacturing (CMC) · Supplement 21 · standardAP
1981-09-30Labeling · Supplement 19AP
1981-09-30Manufacturing (CMC) · Supplement 18 · standardAP
1980-10-24Manufacturing (CMC) · Supplement 17 · standardAP
1980-08-06Manufacturing (CMC) · Supplement 16 · standardAP
1980-07-16Manufacturing (CMC) · Supplement 15 · standardAP
1980-02-12Manufacturing (CMC) · Supplement 14 · standardAP
1979-10-16Manufacturing (CMC) · Supplement 12 · standardAP
1979-10-09Labeling · Supplement 13AP
1979-06-08Manufacturing (CMC) · Supplement 11 · standardAP
1979-03-14Labeling · Supplement 10AP
1979-03-12Manufacturing (CMC) · Supplement 8 · standardAP
1978-11-02Manufacturing (CMC) · Supplement 5 · standardAP
1978-11-02Labeling · Supplement 6AP
1978-10-12Manufacturing (CMC) · Supplement 9 · standardAP
1978-04-28Manufacturing (CMC) · Supplement 7 · 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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