APPLICATION
ANDA078968
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-23
LATEST ACTION
2024-03-15
ROUTE
BUCCAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Discontinued
Products
NICOTINE POLACRILEXDiscontinued
NICOTINE POLACRILEX EQ 4MG BASE · GUM, CHEWING · BUCCAL
Approval history
2024-03-15Labeling · Supplement 10 · standardAP
2024-03-15Labeling · Supplement 13 · standardAP
2012-11-29Labeling · Supplement 8 · standardAP
2010-06-17Labeling · Supplement 4AP
2008-04-23OriginalAP
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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