APPLICATION
NDA010417
TYPE
NDA
ORIGINAL APPROVAL
1959-05-07
LATEST ACTION
2013-03-28
ROUTE
INJECTION, TOPICAL
DOSAGE FORM
INJECTABLE, SOLUTION
MARKETING STATUS
Discontinued
Products
XYLOCAINE 4% PRESERVATIVE FREE · ReferenceDiscontinued
LIDOCAINE HYDROCHLORIDE 4% · INJECTABLE · INJECTION
XYLOCAINE 4% PRESERVATIVE FREE · ReferenceDiscontinued
LIDOCAINE HYDROCHLORIDE 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL
Approval history
2013-03-28Labeling · Supplement 31 · standardAP
2013-03-28Manufacturing (CMC) · Supplement 32 · priorityAP
1999-03-12Labeling · Supplement 22 · standardAP
1996-09-13Manufacturing (CMC) · Supplement 19 · priorityAP
1996-03-11Manufacturing (CMC) · Supplement 21 · priorityAP
1995-07-11Manufacturing (CMC) · Supplement 20 · priorityAP
1994-11-22Manufacturing (CMC) · Supplement 18 · priorityAP
1993-02-18Manufacturing (CMC) · Supplement 17 · priorityAP
1989-07-11Manufacturing (CMC) · Supplement 16 · priorityAP
1987-09-16Manufacturing (CMC) · Supplement 15 · priorityAP
1985-03-25Labeling · Supplement 11AP
1984-06-20Manufacturing (CMC) · Supplement 14 · priorityAP
1982-08-09Manufacturing (CMC) · Supplement 9 · priorityAP
1982-08-09Labeling · Supplement 10AP
1982-06-28Manufacturing (CMC) · Supplement 13 · priorityAP
1982-03-25Manufacturing (CMC) · Supplement 12 · priorityAP
1980-12-04Labeling · Supplement 7AP
1980-12-04Manufacturing (CMC) · Supplement 6 · priorityAP
1980-11-03Manufacturing (CMC) · Supplement 5 · priorityAP
1980-11-03Labeling · Supplement 8AP
1980-06-13Labeling · Supplement 3AP
1979-08-29Labeling · Supplement 4AP
1973-02-01Labeling · Supplement 2AP
1959-05-07Type 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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