APPLICATION
ANDA079044
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-08
LATEST ACTION
2017-04-12
ROUTE
BUCCAL, ORAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Over-the-counter
Products
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · GUM, CHEWING · BUCCAL
Approval history
2017-04-12Labeling · Supplement 15 · standardAP
2015-04-30Labeling · Supplement 10 · standardAP
2013-01-28Labeling · Supplement 8 · standardAP
2009-07-08OriginalAP
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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