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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
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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