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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
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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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