APPLICATION
ANDA091349
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-20
LATEST ACTION
2024-03-15
ROUTE
ORAL, 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
2024-03-15Labeling · Supplement 15 · standardAP
2016-03-30Labeling · Supplement 8 · standardAP
2012-11-29Labeling · Supplement 7 · standardAP
2012-04-19Labeling · Supplement 3AP
2011-12-15Labeling · Supplement 2AP
2011-07-20OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.