APPLICATION
NDA020575
TYPE
NDA
ORIGINAL APPROVAL
1996-05-21
LATEST ACTION
2001-10-30
ROUTE
BUCCAL, TOPICAL
DOSAGE FORM
FILM, EXTENDED RELEASE, PATCH
MARKETING STATUS
Discontinued
Products
DENTIPATCHDiscontinued
LIDOCAINE 23MG/PATCH · FILM, EXTENDED RELEASE · BUCCAL
DENTIPATCHDiscontinued
LIDOCAINE 46.1MG/PATCH · PATCH · TOPICAL
Approval history
2001-10-30Manufacturing (CMC) · Supplement 7 · standardAP
2001-07-12Manufacturing (CMC) · Supplement 6 · standardAP
1999-03-11Labeling · Supplement 5 · standardAP
1998-09-04Manufacturing (CMC) · Supplement 4 · standardAP
1998-09-04Manufacturing (CMC) · Supplement 3 · standardAP
1996-05-21Type 3 - New Dosage Form · 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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