APPLICATION
NDA017995
TYPE
NDA
ORIGINAL APPROVAL
1978-04-24
LATEST ACTION
1985-05-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXTROSE 60% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 60GM/100ML · INJECTABLE · INJECTION
DEXTROSE 60%Discontinued
DEXTROSE 60GM/100ML · INJECTABLE · INJECTION
Approval history
1985-05-16Labeling · Supplement 5 · standardAP
1982-09-22Labeling · Supplement 2 · standardAP
1981-05-04Manufacturing (CMC) · Supplement 1 · standardAP
1978-04-24Type 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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