NDA 020714

PHARMACIA AND UPJOHN

FDA Drug Application

Application #020714

Documents

• Letter: 2002-09-08
• Letter: 2003-11-25
• Letter: 2004-07-21
• Letter: 2009-07-08
• Review: 2003-08-08
• Label: 2019-08-30
• Letter: 2019-09-03

Application Sponsors

NDA 020714

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

INHALANT;ORAL

4MG/CARTRIDGE

1

NICOTROL

NICOTINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-05-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	1997-10-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	1999-01-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-11-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	1999-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-11-02	STANDARD
LABELING; Labeling	SUPPL	7	AP	2001-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-11-16	STANDARD
LABELING; Labeling	SUPPL	10	AP	2002-09-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2003-11-06	STANDARD
LABELING; Labeling	SUPPL	12	AP	2004-07-16	STANDARD
LABELING; Labeling	SUPPL	16	AP	2009-06-17	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-08-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	18	Null	6

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20714
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICOTROL","activeIngredients":"NICOTINE","strength":"4MG\/CARTRIDGE","dosageForm":"INHALANT;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/29\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020714s018lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NICOTROL","submission":"NICOTINE","actionType":"4MG\/CARTRIDGE","submissionClassification":"INHALANT;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-08-29
        )

)