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FDA NDA · NDA020714

NICOTROL

Sponsor: PFIZER

APPLICATION
NDA020714
TYPE
NDA
ORIGINAL APPROVAL
1997-05-02
LATEST ACTION
2024-05-23
ROUTE
ORAL
DOSAGE FORM
INHALANT
MARKETING STATUS
Discontinued

Products

NICOTROL · ReferenceDiscontinued
NICOTINE 4MG/CARTRIDGE · INHALANT · ORAL

Approval history

2024-05-23Labeling · Supplement 19 · standard — Letter ↗AP
2019-08-29Labeling · Supplement 18 · standard — Label ↗AP
2009-06-17Labeling · Supplement 16 · standard — Letter ↗AP
2004-07-16Labeling · Supplement 12 · standard — Letter ↗AP
2003-11-06Labeling · Supplement 11 · standard — Letter ↗AP
2002-09-08Labeling · Supplement 10 · standard — Letter ↗AP
2001-11-16Manufacturing (CMC) · Supplement 8 · standardAP
2001-07-09Labeling · Supplement 7 · standardAP
1999-02-25Labeling · Supplement 5 · standardAP
1999-01-14Labeling · Supplement 3 · standardAP
1998-11-18Manufacturing (CMC) · Supplement 4 · standardAP
1998-11-02Manufacturing (CMC) · Supplement 6 · standardAP
1997-10-29Labeling · Supplement 2 · standardAP
1997-09-24Manufacturing (CMC) · Supplement 1 · standardAP
1997-05-02Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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