ELI LILLY AND CO FDA Approval NDA 022504

NDA 022504

ELI LILLY AND CO

FDA Drug Application

Application #022504

Documents

Letter2014-06-23
Label2011-04-01
Label2011-12-23
Label2015-05-13
Review2011-09-16
Letter2010-11-29
Letter2011-04-04
Letter2011-12-28
Letter2015-05-13
Label2010-11-23
Label2014-06-23
Review2014-07-07
Other2011-04-04
Summary Review2011-09-16
Letter2016-10-27
Label2016-11-01
Letter2017-01-27
Label2017-02-06
Letter2017-02-07
Label2017-07-14
Medication Guide2017-07-14
Letter2017-07-14

Application Sponsors

NDA 022504ELI LILLY AND CO

Marketing Status

Discontinued001

Application Products

001SOLUTION, METERED;TRANSDERMAL30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1AXIRONTESTOSTERONE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2010-11-23STANDARD
REMS; REMSSUPPL2AP2011-03-31N/A
LABELING; LabelingSUPPL5AP2011-12-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2014-01-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2013-05-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2014-02-27STANDARD
LABELING; LabelingSUPPL11AP2014-06-19STANDARD
LABELING; LabelingSUPPL12AP2015-05-11STANDARD
LABELING; LabelingSUPPL13AP2017-02-03STANDARD
LABELING; LabelingSUPPL14AP2016-10-25STANDARD
REMS; REMSSUPPL15AP2017-01-23N/A
LABELING; LabelingSUPPL16AP2017-07-13STANDARD

Submissions Property Types

ORIG1Null40
SUPPL2Null7
SUPPL5Null6
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL11Null7
SUPPL12Null15
SUPPL13Null6
SUPPL14Null6
SUPPL15Null7
SUPPL16Null7

CDER Filings

ELI LILLY AND CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22504
            [companyName] => ELI LILLY AND CO
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/022504s016lbl.pdf#page=15"]
            [products] => [{"drugName":"AXIRON","activeIngredients":"TESTOSTERONE","strength":"30MG\/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION, METERED;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/13\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022504s016lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022504s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022504s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022504s013lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022504s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022504s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022504s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-12","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022504s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022504s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022504s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2011","submission":"SUPPL-2","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022504s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2011","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022504s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022504s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"AXIRON","submission":"TESTOSTERONE","actionType":"30MG\/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION, METERED;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-07-13
        )

)
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