ANDA 074612

AVEVA

FDA Drug Application

Application #074612

Application Sponsors

ANDA 074612

AVEVA

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002
• Over-the-counter: 003

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	21MG/24HR	0	NICOTINE	NICOTINE
002	FILM, EXTENDED RELEASE;TRANSDERMAL	7MG/24HR	0	NICOTINE	NICOTINE
003	FILM, EXTENDED RELEASE;TRANSDERMAL	14MG/24HR	0	NICOTINE	NICOTINE

FDA Submissions

	ORIG	1	AP	1997-10-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-02-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-02-15
LABELING; Labeling	SUPPL	7	AP	2007-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-02-27
LABELING; Labeling	SUPPL	16	AP	2010-02-16
LABELING; Labeling	SUPPL	25	AP	2015-04-13	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	16	Null	8
SUPPL	25	Null	15

CDER Filings

AVEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74612
            [companyName] => AVEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICOTINE","activeIngredients":"NICOTINE","strength":"21MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"NICOTINE","activeIngredients":"NICOTINE","strength":"7MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"NICOTINE","activeIngredients":"NICOTINE","strength":"14MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NICOTINE","submission":"NICOTINE","actionType":"21MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"NICOTINE","submission":"NICOTINE","actionType":"7MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"NICOTINE","submission":"NICOTINE","actionType":"14MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)