AVEVA FDA Approval NDA 019983

NDA 019983

AVEVA

FDA Drug Application

Application #019983

Documents

Letter1998-12-23
Letter1998-12-23
Letter2002-01-18
Letter2002-10-04
Label2002-01-18
Review1998-12-23
Review1998-12-23

Application Sponsors

NDA 019983AVEVA

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001Film, Extended Release; Transdermal11MG/24HR0PROSTEPNICOTINE
002Film, Extended Release; Transdermal22MG/24HR0PROSTEPNICOTINE
003FILM, EXTENDED RELEASE;TRANSDERMAL11MG/24HR0PROSTEPNICOTINE
004FILM, EXTENDED RELEASE;TRANSDERMAL22MG/24HR0PROSTEPNICOTINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1992-01-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1993-04-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1993-02-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1993-02-02STANDARD
LABELING; LabelingSUPPL8AP1996-01-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1998-12-23STANDARD
EFFICACY; EfficacySUPPL12AP1998-12-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2000-04-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-05-07STANDARD
LABELING; LabelingSUPPL16AP2002-01-18STANDARD
LABELING; LabelingSUPPL17AP2002-10-04STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL11Null0
SUPPL13Null0
SUPPL14Null0

CDER Filings

AVEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19983
            [companyName] => AVEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROSTEP","activeIngredients":"NICOTINE","strength":"11MG\/24HR","dosageForm":"Film, Extended Release; Transdermal","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROSTEP","activeIngredients":"NICOTINE","strength":"22MG\/24HR","dosageForm":"Film, Extended Release; Transdermal","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROSTEP","activeIngredients":"NICOTINE","strength":"11MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROSTEP","activeIngredients":"NICOTINE","strength":"22MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/18\/2002","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19983s16lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROSTEP","submission":"NICOTINE","actionType":"11MG\/24HR","submissionClassification":"Film, Extended Release; Transdermal","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROSTEP","submission":"NICOTINE","actionType":"22MG\/24HR","submissionClassification":"Film, Extended Release; Transdermal","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROSTEP","submission":"NICOTINE","actionType":"11MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROSTEP","submission":"NICOTINE","actionType":"22MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-01-18
        )

)

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