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FDA ANDA · ANDA077007
FOSTER AND THRIVE NICOTINE
nicotine polacrilex
Sponsor: PERRIGO R AND D
APPLICATION
ANDA077007
TYPE
ANDA
ORIGINAL APPROVAL
2006-01-31
LATEST ACTION
2025-04-01
ROUTE
ORAL
DOSAGE FORM
TROCHE/LOZENGE
MARKETING STATUS
Over-the-counter
Products
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · TROCHE/LOZENGE · ORAL
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 4MG BASE · TROCHE/LOZENGE · ORAL
Approval history
2025-04-01Manufacturing (CMC) · Supplement 55 · unknownAP
2024-07-12Manufacturing (CMC) · Supplement 51 · unknownAP
2016-06-19Labeling · Supplement 34 · standardAP
2015-04-03Labeling · Supplement 28 · standardAP
2014-11-03Labeling · Supplement 23 · standardAP
2014-10-22Manufacturing (CMC) · Supplement 24 · unknownAP
2008-04-14Labeling · Supplement 10AP
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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