← FDA DRUG APPROVALS

FDA ANDA · ANDA074507

RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR

nicotine polacrilex

Sponsor: P AND L

APPLICATION
ANDA074507
TYPE
ANDA
ORIGINAL APPROVAL
1999-03-15
LATEST ACTION
2017-04-17
ROUTE
BUCCAL, ORAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Over-the-counter

Products

NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · GUM, CHEWING · BUCCAL

Approval history

2017-04-17Labeling · Supplement 59 · standardAP
2015-04-30Labeling · Supplement 55 · standardAP
2013-01-28Labeling · Supplement 53 · standardAP
2009-03-02Labeling · Supplement 39AP
2007-07-23Labeling · Supplement 41AP
2007-03-08Labeling · Supplement 33AP
2006-12-08Labeling · Supplement 35AP
2004-05-25Labeling · Supplement 28AP
2003-06-10Labeling · Supplement 23AP
2002-10-15Manufacturing (CMC) · Supplement 19AP
2002-10-15Manufacturing (CMC) · Supplement 21AP
2002-10-15Manufacturing (CMC) · Supplement 18AP
2002-10-15Manufacturing (CMC) · Supplement 20AP
2002-04-30Labeling · Supplement 17AP
2002-02-19Manufacturing (CMC) · Supplement 10AP
2001-08-08Manufacturing (CMC) · Supplement 5AP
2001-02-22Manufacturing (CMC) · Supplement 1AP
2001-01-22Manufacturing (CMC) · Supplement 4AP
2000-03-31Manufacturing (CMC) · Supplement 2AP
1999-12-27Labeling · Supplement 3AP
1999-03-15Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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