ABBVIE FDA Approval NDA 021015

NDA 021015

ABBVIE

FDA Drug Application

Application #021015

Documents

Letter2000-02-28
Letter2002-10-22
Letter2005-08-16
Letter2004-12-02
Letter2005-08-19
Letter2008-01-09
Letter2008-01-09
Letter2009-10-26
Letter2011-03-14
Letter2014-06-23
Label2000-02-28
Label2004-12-03
Label2008-01-08
Label2009-10-01
Label2011-03-11
Label2012-09-24
Label2013-05-20
Label2014-06-23
Label2015-05-13
Review2004-01-15
Review2006-06-01
Review2006-06-01
Other2011-04-04
Letter2003-09-29
Letter2003-09-30
Letter2008-01-09
Letter2011-12-05
Letter2012-09-24
Letter2013-05-22
Letter2014-11-14
Letter2015-05-13
Label2002-10-22
Label2005-08-19
Label2007-12-14
Label2008-01-08
Label2011-12-02
Label2014-12-18
Letter2016-10-27
Label2016-11-01
Pediatric Written Request1900-01-01
Pediatric Written Request1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2019-02-28
Label2019-03-08
Letter2019-05-14
Label2019-05-16
Medication Guide2019-05-16
Letter2019-06-03

Application Sponsors

NDA 021015ABBVIE

Marketing Status

Prescription001
Prescription002
Discontinued003

Application Products

001GEL;TRANSDERMAL25MG/2.5GM PACKET1ANDROGELTESTOSTERONE
002GEL;TRANSDERMAL50MG/5GM PACKET1ANDROGELTESTOSTERONE
003GEL, METERED;TRANSDERMAL12.5MG/1.25GM ACTUATION1ANDROGELTESTOSTERONE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2000-02-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2001-01-23
LABELING; LabelingSUPPL3AP2001-09-05STANDARD
LABELING; LabelingSUPPL4AP2002-10-22STANDARD
LABELING; LabelingSUPPL5AP2001-06-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2001-08-09
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-09-18
LABELING; LabelingSUPPL8AP2003-09-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2003-09-26
EFFICACY; EfficacySUPPL11AP2005-08-11UNKNOWN
LABELING; LabelingSUPPL12AP2004-11-19STANDARD
LABELING; LabelingSUPPL13AP2005-08-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2006-07-14N/A
LABELING; LabelingSUPPL16AP2007-12-13STANDARD
LABELING; LabelingSUPPL19AP2007-12-27STANDARD
LABELING; LabelingSUPPL20AP2007-12-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2009-03-19N/A
LABELING; LabelingSUPPL22AP2009-09-18STANDARD
LABELING; LabelingSUPPL28AP2011-03-10STANDARD
REMS; REMSSUPPL32AP2011-11-30N/A
MANUF (CMC); Manufacturing (CMC)SUPPL33AP2012-11-19
LABELING; LabelingSUPPL34AP2012-09-20UNKNOWN
LABELING; LabelingSUPPL36AP2013-05-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2014-02-27
LABELING; LabelingSUPPL38AP2014-11-12STANDARD
LABELING; LabelingSUPPL39AP2014-06-19STANDARD
LABELING; LabelingSUPPL40AP2015-05-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL41AP2015-08-17
LABELING; LabelingSUPPL43AP2016-10-25STANDARD
LABELING; LabelingSUPPL44AP2019-02-25STANDARD
LABELING; LabelingSUPPL45AP2019-05-10STANDARD
REMS; REMSSUPPL46AP2019-05-30N/A

Submissions Property Types

SUPPL2Null0
SUPPL6Null0
SUPPL7Null0
SUPPL10Null0
SUPPL22Null7
SUPPL28Null6
SUPPL32Null6
SUPPL33Null0
SUPPL34Null15
SUPPL36Null7
SUPPL37Null0
SUPPL38Null15
SUPPL39Null6
SUPPL40Null6
SUPPL41Null0
SUPPL43Null7
SUPPL44Null7
SUPPL45Null15
SUPPL46Null6

TE Codes

001PrescriptionAB1
002PrescriptionAB1

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21015
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021015s045lbl.pdf#page=23"]
            [products] => [{"drugName":"ANDROGEL","activeIngredients":"TESTOSTERONE","strength":"25MG\/2.5GM PACKET","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ANDROGEL","activeIngredients":"TESTOSTERONE","strength":"50MG\/5GM PACKET","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ANDROGEL","activeIngredients":"TESTOSTERONE","strength":"12.5MG\/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"GEL, METERED;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/10\/2019","submission":"SUPPL-45","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021015s045lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2019","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021015s044lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2016","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021015s043lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021015s040lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-40","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021015s040lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021015s040lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2014","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021015Orig1s038lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2014","submission":"SUPPL-38","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021015Orig1s038lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2014","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021015s039lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2013","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021015s036lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2013","submission":"SUPPL-36","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021015s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2012","submission":"SUPPL-34","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021015Orig1s034lbledt.pdf\"}]","notes":""},{"actionDate":"09\/20\/2012","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021015Orig1s034lbledt.pdf\"}]","notes":""},{"actionDate":"09\/20\/2012","submission":"SUPPL-34","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021015Orig1s034lbledt.pdf\"}]","notes":""},{"actionDate":"11\/30\/2011","submission":"SUPPL-32","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021015s032lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2011","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021015s028lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2009","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021015s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2009","submission":"SUPPL-22","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021015s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/27\/2007","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021015s019s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/27\/2007","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021015s019s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2007","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021015s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2005","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021015s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2004","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21015s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2002","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21015s4lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21015lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ANDROGEL","submission":"TESTOSTERONE","actionType":"25MG\/2.5GM PACKET","submissionClassification":"GEL;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANDROGEL","submission":"TESTOSTERONE","actionType":"50MG\/5GM PACKET","submissionClassification":"GEL;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANDROGEL","submission":"TESTOSTERONE","actionType":"12.5MG\/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"GEL, METERED;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-10
        )

)
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