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FDA ANDA · ANDA076290

LIDOCAINE AND PRILOCAINE

Sponsor: HIKMA

APPLICATION
ANDA076290
TYPE
ANDA
ORIGINAL APPROVAL
2003-09-25
LATEST ACTION
2010-06-22
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

LIDOCAINE AND PRILOCAINEDiscontinued
LIDOCAINE 2.5%, PRILOCAINE 2.5% · CREAM · TOPICAL

Approval history

2010-06-22Labeling · Supplement 3AP
2010-06-22Labeling · Supplement 2AP
2009-07-01Labeling · Supplement 1AP
2003-09-25OriginalAP
VIEW ON DRUGS@FDA ↗

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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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