APPLICATION
ANDA203690
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-09
LATEST ACTION
2019-12-27
ROUTE
ORAL
DOSAGE FORM
TROCHE/LOZENGE
MARKETING STATUS
Over-the-counter
Products
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 4MG BASE · TROCHE/LOZENGE · ORAL
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · TROCHE/LOZENGE · ORAL
Approval history
2019-12-27Manufacturing (CMC) · Supplement 22AP
2018-11-01Manufacturing (CMC) · Supplement 17 · unknownAP
2018-11-01Manufacturing (CMC) · Supplement 18AP
2016-01-14Labeling · Supplement 10 · standardAP
2016-01-14Labeling · Supplement 4 · standardAP
2016-01-14Labeling · Supplement 7 · standardAP
2014-06-30Manufacturing (CMC) · Supplement 3 · unknownAP
2012-10-09UNKNOWN · OriginalAP
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.