NDA 020385

PFIZER INC

FDA Drug Application

Application #020385

Documents

• Letter: 2003-11-25
• Letter: 2004-07-21
• Letter: 2002-09-08
• Letter: 2010-07-01
• Label: 2010-07-01
• Label: 2019-08-30
• Letter: 2019-09-03

Application Sponsors

NDA 020385

PFIZER INC

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.5MG/SPRAY

1

NICOTROL

NICOTINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-03-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	2001-07-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2002-09-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	2003-11-06	STANDARD
LABELING; Labeling	SUPPL	7	AP	2004-07-16	STANDARD
LABELING; Labeling	SUPPL	10	AP	2010-06-29	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2019-08-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	10	Null	7
SUPPL	11	Null	7

CDER Filings

PFIZER INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20385
            [companyName] => PFIZER INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICOTROL","activeIngredients":"NICOTINE","strength":"0.5MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/29\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020385s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2010","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020385s010lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NICOTROL","submission":"NICOTINE","actionType":"0.5MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-08-29
        )

)