APPLICATION
NDA016297
TYPE
NDA
ORIGINAL APPROVAL
1968-11-04
LATEST ACTION
1993-02-18
ROUTE
SPINAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
XYLOCAINE 1.5% W/ DEXTROSE 7.5%Discontinued
LIDOCAINE HYDROCHLORIDE 1.5% · INJECTABLE · SPINAL
Approval history
1993-02-18Manufacturing (CMC) · Supplement 12 · priorityAP
1988-05-31Labeling · Supplement 11AP
1987-09-16Manufacturing (CMC) · Supplement 10 · priorityAP
1984-09-19Labeling · Supplement 9AP
1984-06-20Manufacturing (CMC) · Supplement 8 · priorityAP
1982-03-25Manufacturing (CMC) · Supplement 7 · priorityAP
1979-08-29Labeling · Supplement 6AP
1978-05-15Manufacturing (CMC) · Supplement 4 · priorityAP
1977-06-28Labeling · Supplement 3AP
1974-12-30Labeling · Supplement 1AP
1968-11-04Type 3 - New Dosage Form · Original · priorityAP
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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