APPLICATION
NDA019222
TYPE
NDA
ORIGINAL APPROVAL
1984-07-13
LATEST ACTION
1999-01-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 50MG/ML · INJECTABLE · INJECTION
Approval history
1999-01-22Manufacturing (CMC) · Supplement 7 · standardAP
1998-09-17Manufacturing (CMC) · Supplement 6 · standardAP
1997-08-22Labeling · Supplement 5 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 4 · standardAP
1994-03-25Manufacturing (CMC) · Supplement 3 · standardAP
1986-08-11Manufacturing (CMC) · Supplement 1 · standardAP
1984-07-13Type 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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