← FDA DRUG APPROVALS
FDA ANDA · ANDA078699
RUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR
nicotine polacrilex
Sponsor: P AND L
APPLICATION
ANDA078699
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-29
LATEST ACTION
2017-04-14
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
2017-04-14Labeling · Supplement 15 · standardAP
2015-04-30Labeling · Supplement 11 · standardAP
2013-01-28Labeling · Supplement 9 · standardAP
2008-12-29OriginalAP
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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