APPLICATION
NDA008048
TYPE
NDA
ORIGINAL APPROVAL
1951-05-17
LATEST ACTION
2000-12-04
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
XYLOCAINE · ReferenceDiscontinued
LIDOCAINE 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL
Approval history
2000-12-04Manufacturing (CMC) · Supplement 17 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 14 · standardAP
1996-05-02Manufacturing (CMC) · Supplement 15 · standardAP
1996-05-02Manufacturing (CMC) · Supplement 16 · standardAP
1993-02-18Manufacturing (CMC) · Supplement 13 · standardAP
1991-07-11Manufacturing (CMC) · Supplement 12 · standardAP
1990-04-27Manufacturing (CMC) · Supplement 11 · standardAP
1987-09-16Manufacturing (CMC) · Supplement 9 · standardAP
1987-04-07Manufacturing (CMC) · Supplement 10 · standardAP
1986-07-24Labeling · Supplement 8 · standardAP
1985-11-21Labeling · Supplement 5 · standardAP
1984-06-15Manufacturing (CMC) · Supplement 7 · standardAP
1982-03-25Manufacturing (CMC) · Supplement 6 · standardAP
1980-06-16Labeling · Supplement 4 · standardAP
1951-05-17Type 2 - New Active Ingredient · 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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