ABBVIE FDA Approval NDA 022309

NDA 022309

ABBVIE

FDA Drug Application

Application #022309

Documents

Letter2011-05-05
Letter2014-11-18
Letter2014-06-23
Label2013-05-20
Label2014-11-20
Review2011-11-17
Review2014-01-16
Letter2012-09-10
Letter2013-03-15
Letter2013-05-22
Letter2015-05-13
Label2011-04-29
Label2012-09-11
Label2014-06-23
Label2015-05-13
Summary Review2011-11-17
Letter2016-10-27
Label2016-11-01
REMS2016-11-02
Letter2019-02-28
Label2019-03-07
Letter2019-05-13
Label2019-05-16
Medication Guide2019-05-16
Letter2019-06-03

Application Sponsors

NDA 022309ABBVIE

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001GEL, METERED;TRANSDERMAL1.62% (20.25MG/1.25GM ACTUATION)1ANDROGELTESTOSTERONE
002GEL;TRANSDERMAL1.62% (20.25MG/1.25GM PACKET)1ANDROGELTESTOSTERONE
003GEL;TRANSDERMAL1.62% (40.5MG/2.5GM PACKET)1ANDROGELTESTOSTERONE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2011-04-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2012-11-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2013-03-13STANDARD
LABELING; LabelingSUPPL7AP2013-03-12STANDARD
LABELING; LabelingSUPPL8AP2013-05-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2014-02-28STANDARD
LABELING; LabelingSUPPL11AP2014-11-14STANDARD
LABELING; LabelingSUPPL12AP2014-06-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2015-06-11STANDARD
LABELING; LabelingSUPPL14AP2015-05-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2015-08-17STANDARD
LABELING; LabelingSUPPL17AP2016-10-25STANDARD
LABELING; LabelingSUPPL18AP2019-02-25STANDARD
LABELING; LabelingSUPPL20AP2019-05-10STANDARD
REMS; REMSSUPPL21AP2019-05-30N/A

Submissions Property Types

ORIG1Null7
SUPPL3Null0
SUPPL5Null0
SUPPL7Null7
SUPPL8Null15
SUPPL10Null0
SUPPL11Null15
SUPPL12Null15
SUPPL13Null0
SUPPL14Null15
SUPPL15Null0
SUPPL17Null7
SUPPL18Null7
SUPPL20Null7
SUPPL21Null15

TE Codes

001PrescriptionAB
002PrescriptionAB2
003PrescriptionAB2

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22309
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022309s020lbl.pdf#page=25"]
            [products] => [{"drugName":"ANDROGEL","activeIngredients":"TESTOSTERONE","strength":"1.62% (20.25MG\/1.25GM ACTUATION)","dosageForm":"GEL, METERED;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ANDROGEL","activeIngredients":"TESTOSTERONE","strength":"1.62% (20.25MG\/1.25GM PACKET)","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ANDROGEL","activeIngredients":"TESTOSTERONE","strength":"1.62% (40.5MG\/2.5GM PACKET)","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/10\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022309s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022309s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022309s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022309s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-14","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022309s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022309s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022309s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2014","submission":"SUPPL-11","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022309s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022309s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022309s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022309s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022309s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2012","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022309s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022309s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ANDROGEL","submission":"TESTOSTERONE","actionType":"1.62% (20.25MG\/1.25GM ACTUATION)","submissionClassification":"GEL, METERED;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANDROGEL","submission":"TESTOSTERONE","actionType":"1.62% (20.25MG\/1.25GM PACKET)","submissionClassification":"GEL;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANDROGEL","submission":"TESTOSTERONE","actionType":"1.62% (40.5MG\/2.5GM PACKET)","submissionClassification":"GEL;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-10
        )

)
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