APPLICATION
NDA009470
TYPE
NDA
ORIGINAL APPROVAL
1954-09-02
LATEST ACTION
2014-09-24
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
XYLOCAINE VISCOUS · ReferenceDiscontinued
LIDOCAINE HYDROCHLORIDE 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL
Approval history
1996-05-31Manufacturing (CMC) · Supplement 22 · priorityAP
1996-04-29Manufacturing (CMC) · Supplement 21 · priorityAP
1994-04-18Labeling · Supplement 20 · standardAP
1993-10-26Manufacturing (CMC) · Supplement 18 · priorityAP
1993-02-18Manufacturing (CMC) · Supplement 19 · priorityAP
1989-09-14Manufacturing (CMC) · Supplement 17 · priorityAP
1987-09-16Manufacturing (CMC) · Supplement 16 · priorityAP
1984-06-20Manufacturing (CMC) · Supplement 15 · priorityAP
1983-07-29Labeling · Supplement 12AP
1982-03-25Manufacturing (CMC) · Supplement 13 · priorityAP
1981-02-11Manufacturing (CMC) · Supplement 11 · priorityAP
1980-05-05Manufacturing (CMC) · Supplement 9 · priorityAP
1980-05-05Labeling · Supplement 10AP
1978-12-14Manufacturing (CMC) · Supplement 8 · priorityAP
1977-02-03Labeling · Supplement 5AP
1977-01-12Manufacturing (CMC) · Supplement 4 · priorityAP
1976-05-27Manufacturing (CMC) · Supplement 3 · priorityAP
1976-03-05Labeling · Supplement 2AP
1972-05-03Labeling · Supplement 1AP
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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