APPLICATION
NDA004589
TYPE
NDA
ORIGINAL APPROVAL
1946-01-17
LATEST ACTION
1985-10-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ALCOHOL 5% AND DEXTROSE 5%Discontinued
ALCOHOL 5ML/100ML, DEXTROSE 5GM/100ML · INJECTABLE · INJECTION
Approval history
1985-10-11Labeling · Supplement 11AP
1985-06-14Manufacturing (CMC) · Supplement 10AP
1984-07-09Manufacturing (CMC) · Supplement 7AP
1982-10-04Labeling · Supplement 6AP
1982-01-19Labeling · Supplement 5AP
1980-10-01Manufacturing (CMC) · Supplement 4AP
1978-02-16Manufacturing (CMC) · Supplement 3AP
1977-06-28Manufacturing (CMC) · Supplement 1AP
1977-06-28Labeling · Supplement 2AP
1946-01-17OriginalAP
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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