APPLICATION
ANDA077850
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-18
LATEST ACTION
2013-09-19
ROUTE
BUCCAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Discontinued
Products
NICOTINE POLACRILEXDiscontinued
NICOTINE POLACRILEX EQ 4MG BASE · GUM, CHEWING · BUCCAL
Approval history
2013-09-19Labeling · Supplement 3 · standardAP
2012-11-20Labeling · Supplement 2AP
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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