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FDA ANDA · ANDA078547
FOSTER AND THRIVE NICOTINE
nicotine polacrilex
Sponsor: PERRIGO R AND D
APPLICATION
ANDA078547
TYPE
ANDA
ORIGINAL APPROVAL
2007-05-24
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 20 · standardAP
2014-03-25Labeling · Supplement 14 · standardAP
2012-09-28Labeling · Supplement 13 · standardAP
2012-04-25Labeling · Supplement 11AP
2010-06-17Labeling · Supplement 7AP
2007-05-24OriginalAP
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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