FDA NDA · NDA020385

NICOTROL

nicotine

Sponsor: PFIZER INC

APPLICATION

NDA020385

TYPE

NDA

ORIGINAL APPROVAL

1996-03-22

LATEST ACTION

2024-05-23

ROUTE

NASAL

DOSAGE FORM

SPRAY, METERED

MARKETING STATUS

Prescription

Products

NICOTROL · ReferencePrescription

NICOTINE 0.5MG/SPRAY · SPRAY, METERED · NASAL

2024-05-23Labeling · Supplement 12 · standard — Letter ↗AP

2019-08-29Labeling · Supplement 11 · standard — Label ↗AP

2010-06-29Labeling · Supplement 10 · unknown — Letter ↗AP

2004-07-16Labeling · Supplement 7 · standard — Letter ↗AP

2003-11-06Labeling · Supplement 6 · standard — Letter ↗AP

2002-09-08Labeling · Supplement 5 · standard — Letter ↗AP

2001-07-09Labeling · Supplement 3 · standardAP

1998-08-14Manufacturing (CMC) · Supplement 1 · standardAP

1996-03-22Type 3 - New Dosage Form · 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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