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FDA ANDA · ANDA076568
NICOTINE POLACRILEX MINT
nicotine polacrilex
Sponsor: P AND L
APPLICATION
ANDA076568
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2017-04-14
ROUTE
BUCCAL, ORAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Over-the-counter, Discontinued
Products
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 4MG BASE · GUM, CHEWING · BUCCAL
NICOTINE POLACRILEXDiscontinued
NICOTINE POLACRILEX EQ 2MG BASE · GUM, CHEWING · BUCCAL
Approval history
2017-04-14Labeling · Supplement 31 · standardAP
2015-04-30Labeling · Supplement 27 · standardAP
2013-01-28Labeling · Supplement 25 · standardAP
2007-07-16Labeling · Supplement 10AP
2007-03-08Labeling · Supplement 1AP
2006-12-08Labeling · Supplement 3AP
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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