APPLICATION
ANDA076778
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-16
LATEST ACTION
2024-04-30
ROUTE
BUCCAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Discontinued
Products
NICOTINE POLACRILEXDiscontinued
NICOTINE POLACRILEX EQ 4MG BASE · GUM, CHEWING · BUCCAL
Approval history
2024-04-30Labeling · Supplement 19 · standardAP
2012-11-29Labeling · Supplement 16 · standardAP
2010-06-17Labeling · Supplement 13AP
2005-08-15Labeling · Supplement 2AP
2005-07-15Labeling · Supplement 1AP
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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