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FDA ANDA · ANDA076775
GOOD SENSE NICOTINE
nicotine polacrilex
Sponsor: L PERRIGO CO
APPLICATION
ANDA076775
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-16
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 2MG BASE · GUM, CHEWING · BUCCAL
Approval history
2024-03-15Labeling · Supplement 31 · standardAP
2019-11-01Labeling · Supplement 24 · standardAP
2015-04-15Labeling · Supplement 22 · standardAP
2012-11-29Labeling · Supplement 21 · standardAP
2010-06-17Labeling · Supplement 16AP
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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