← FDA DRUG APPROVALS
FDA ANDA · ANDA076320
LIDOCAINE AND PRILOCAINE LIDOCAINE AND PRILOCAINE
lidocaine and prilocaine
Sponsor: ENCUBE
APPLICATION
ANDA076320
TYPE
ANDA
ORIGINAL APPROVAL
2003-08-27
LATEST ACTION
2012-11-28
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
LIDOCAINE AND PRILOCAINEPrescription
LIDOCAINE 2.5%, PRILOCAINE 2.5% · CREAM · TOPICAL
Approval history
2012-11-28Labeling · Supplement 18 · standardAP
2009-10-23Labeling · Supplement 12AP
2007-10-22Labeling · Supplement 8AP
2007-07-10Labeling · Supplement 10AP
2004-08-11Labeling · Supplement 2AP
2003-08-27OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.