ALLERGAN FDA Approval NDA 020489

NDA 020489

ALLERGAN

FDA Drug Application

Application #020489

Documents

Letter2006-05-22
Letter2014-06-23
Label2011-10-25
Label2015-05-13
Review2007-07-06
Letter2002-01-15
Letter2002-08-09
Letter2011-10-25
Letter2012-05-02
Letter2015-05-13
Label2006-05-22
Label2012-05-01
Label2014-06-23
Review1997-05-02
Letter2016-10-27
Label2016-11-01
Review2019-09-19
Review2019-09-20
Label2020-05-12
Letter2020-05-13

Application Sponsors

NDA 020489ALLERGAN

Marketing Status

Discontinued001
Discontinued002
Prescription003
Prescription004

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL2.5MG/24HR0ANDRODERMTESTOSTERONE
002FILM, EXTENDED RELEASE;TRANSDERMAL5MG/24HR0ANDRODERMTESTOSTERONE
003FILM, EXTENDED RELEASE;TRANSDERMAL2MG/24HR1ANDRODERMTESTOSTERONE
004FILM, EXTENDED RELEASE;TRANSDERMAL4MG/24HR1ANDRODERMTESTOSTERONE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1995-09-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1997-04-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1997-05-02STANDARD
LABELING; LabelingSUPPL4AP1998-03-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-06-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-10-09STANDARD
LABELING; LabelingSUPPL7AP2002-01-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-07-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-10-24STANDARD
LABELING; LabelingSUPPL10AP2002-08-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2002-11-27STANDARD
LABELING; LabelingSUPPL13AP2006-05-19STANDARD
EFFICACY; EfficacySUPPL25AP2011-10-20STANDARD
LABELING; LabelingSUPPL27AP2012-04-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL30AP2014-01-16STANDARD
LABELING; LabelingSUPPL31AP2014-06-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2015-04-30STANDARD
LABELING; LabelingSUPPL33AP2015-05-11STANDARD
LABELING; LabelingSUPPL34AP2016-10-25STANDARD
LABELING; LabelingSUPPL36AP2020-05-11STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0
SUPPL9Null0
SUPPL11Null0
SUPPL25Null15
SUPPL27Null15
SUPPL30Null0
SUPPL31Null6
SUPPL32Null0
SUPPL33Null15
SUPPL34Null6
SUPPL36Null6

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20489
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANDRODERM","activeIngredients":"TESTOSTERONE","strength":"2.5MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ANDRODERM","activeIngredients":"TESTOSTERONE","strength":"5MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ANDRODERM","activeIngredients":"TESTOSTERONE","strength":"2MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ANDRODERM","activeIngredients":"TESTOSTERONE","strength":"4MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/11\/2020","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020489s036lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2016","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020489s034lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020489s033lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2014","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020489s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2012","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020489s027lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2011","submission":"SUPPL-25","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020489s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2006","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020489s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ANDRODERM","submission":"TESTOSTERONE","actionType":"2.5MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ANDRODERM","submission":"TESTOSTERONE","actionType":"5MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ANDRODERM","submission":"TESTOSTERONE","actionType":"2MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANDRODERM","submission":"TESTOSTERONE","actionType":"4MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-11
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.