ELI LILLY CO FDA Approval NDA 022332

NDA 022332

ELI LILLY CO

FDA Drug Application

Application #022332

Documents

Letter2009-05-29
Letter2011-02-14
Letter2015-04-03
Label2009-05-25
Label2014-05-02
Label2015-04-07
Review2009-08-03
Letter2013-11-25
Letter2014-04-30
Label2011-02-09
Label2013-11-22
Letter2017-05-09
Label2017-05-09
Letter2020-09-16
Label2020-09-21

Application Sponsors

NDA 022332ELI LILLY CO

Marketing Status

Prescription001

Application Products

001TABLET;ORAL20MG1ADCIRCATADALAFIL

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)ORIG1AP2009-05-22STANDARD
LABELING; LabelingSUPPL3AP2011-02-08UNKNOWN
LABELING; LabelingSUPPL5AP2013-11-20STANDARD
LABELING; LabelingSUPPL6AP2014-04-29STANDARD
LABELING; LabelingSUPPL7AP2015-04-02STANDARD
LABELING; LabelingSUPPL9AP2017-05-05STANDARD
LABELING; LabelingSUPPL11AP2020-09-15STANDARD

Submissions Property Types

ORIG1Null6
SUPPL3Null6
SUPPL5Null15
SUPPL6Null6
SUPPL7Null6
SUPPL9Null7
SUPPL11Null15

TE Codes

001PrescriptionAB2

CDER Filings

ELI LILLY CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22332
            [companyName] => ELI LILLY CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADCIRCA","activeIngredients":"TADALAFIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/05\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022332s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022332s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022332s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022332s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2011","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022332s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022332lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ADCIRCA","submission":"TADALAFIL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-05-05
        )

)

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