APPLICATION
ANDA213233
TYPE
ANDA
ORIGINAL APPROVAL
2020-08-04
LATEST ACTION
2020-12-15
ROUTE
ORAL
DOSAGE FORM
TROCHE/LOZENGE
MARKETING STATUS
Over-the-counter
Products
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · TROCHE/LOZENGE · ORAL
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 4MG BASE · TROCHE/LOZENGE · ORAL
Approval history
2020-12-15Labeling · Supplement 1 · standardAP
2020-08-04UNKNOWN · 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.
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.