APPLICATION
NDA018358
TYPE
NDA
ORIGINAL APPROVAL
1980-04-29
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXTROSE 2.5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 2.5GM/100ML · INJECTABLE · INJECTION
Approval history
1990-09-11Manufacturing (CMC) · Supplement 12 · standardAP
1986-02-18Manufacturing (CMC) · Supplement 6 · standardAP
1985-06-28Manufacturing (CMC) · Supplement 7 · standardAP
1985-06-26Labeling · Supplement 10 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 8 · standardAP
1983-01-24Labeling · Supplement 4 · standardAP
1981-10-26Manufacturing (CMC) · Supplement 5 · standardAP
1980-12-12Manufacturing (CMC) · Supplement 2 · standardAP
1980-10-24Manufacturing (CMC) · Supplement 1 · standardAP
1980-04-29Type 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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