APPLICATION
ANDA090711
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-10
LATEST ACTION
2016-07-21
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
2016-07-21Labeling · Supplement 20AP
2016-06-23Manufacturing (CMC) · Supplement 16 · unknownAP
2016-06-23Labeling · Supplement 14 · standardAP
2016-06-23Labeling · Supplement 10 · standardAP
2009-07-10OriginalAP
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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