APPLICATION
NDA019893
TYPE
NDA
ORIGINAL APPROVAL
1989-12-26
LATEST ACTION
2003-12-18
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 70% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 70GM/100ML · INJECTABLE · INJECTION
Approval history
2003-12-18Labeling · Supplement 16AP
2002-11-01Manufacturing (CMC) · Supplement 14 · standardAP
1999-07-16Labeling · Supplement 13AP
1999-05-19Labeling · Supplement 12AP
1999-01-05Labeling · Supplement 11AP
1997-08-22Labeling · Supplement 10AP
1996-08-27Manufacturing (CMC) · Supplement 7 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 9 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 8 · standardAP
1993-12-13Manufacturing (CMC) · Supplement 6 · standardAP
1993-01-21Manufacturing (CMC) · Supplement 4 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 3 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 2 · standardAP
1990-07-31Manufacturing (CMC) · Supplement 1 · standardAP
1989-12-26Type 5 - New Formulation or New Manufacturer · Original · 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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