APPLICATION
ANDA078326
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-30
LATEST ACTION
2024-03-15
ROUTE
ORAL, BUCCAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Over-the-counter
Products
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 4MG BASE · GUM, CHEWING · BUCCAL
Approval history
2024-03-15Labeling · Supplement 20 · standardAP
2019-11-01Labeling · Supplement 15 · standardAP
2015-04-15Labeling · Supplement 14 · standardAP
2012-11-29Labeling · Supplement 13 · standardAP
2010-06-17Labeling · Supplement 9AP
2006-10-30OriginalAP
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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