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FDA ANDA · ANDA204794

NICOTINE POLACRILEX COATED ICE MINT

nicotine polacrilex

Sponsor: P AND L

APPLICATION
ANDA204794
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-10
LATEST ACTION
2016-05-10
ROUTE
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

2016-05-10UNKNOWN · Original · standardAP
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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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