APPLICATION
ANDA078967
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-23
LATEST ACTION
2024-03-27
ROUTE
BUCCAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Discontinued
Products
NICOTINE POLACRILEXDiscontinued
NICOTINE POLACRILEX EQ 2MG BASE · GUM, CHEWING · BUCCAL
Approval history
2024-03-27Labeling · Supplement 11 · standardAP
2024-03-27Labeling · Supplement 14 · standardAP
2012-11-29Labeling · Supplement 9 · standardAP
2010-06-17Labeling · Supplement 5AP
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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