APPLICATION
ANDA215276
TYPE
ANDA
ORIGINAL APPROVAL
2025-07-17
LATEST ACTION
2026-05-12
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
2026-05-12Labeling · Supplement 1 · standardAP
2025-07-17UNKNOWN · 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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