LILLY FDA Approval NDA 021368

NDA 021368

LILLY

FDA Drug Application

Application #021368

Documents

Letter2003-11-21
Letter2005-04-06
Letter2005-07-15
Letter2006-10-26
Letter2008-01-09
Letter2007-10-22
Letter2008-08-13
Letter2010-02-16
Letter2011-10-12
Letter2013-10-11
Letter2015-09-17
Letter2016-04-26
Label2005-04-06
Label2005-04-06
Label2005-07-08
Label2007-01-24
Label2006-03-10
Label2006-10-25
Label2006-10-25
Label2008-01-08
Label2007-10-18
Label2010-02-16
Label2011-10-07
Label2014-05-02
Label2015-09-23
Review2014-01-17
Letter2005-04-06
Letter2007-01-25
Letter2006-03-23
Letter2006-10-26
Letter2011-10-12
Letter2014-04-30
Label2003-11-21
Label2011-10-07
Label2013-10-17
Label2016-04-29
Review2004-03-08
Patient Package Insert2003-11-21
Other Important Information from FDA2005-07-28
Label2017-05-08
Letter2017-05-09
Pediatric Written Request2017-11-16
Pediatric Written Request2017-11-16
Pediatric Amendment 22017-11-16
Pediatric Amendment 32017-11-16
Label2018-02-16
Letter2018-02-23
Pediatric Amendment 11900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01

Application Sponsors

NDA 021368LILLY

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL5MG1CIALISTADALAFIL
002TABLET;ORAL10MG1CIALISTADALAFIL
003TABLET;ORAL20MG1CIALISTADALAFIL
004TABLET;ORAL2.5MG1CIALISTADALAFIL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2003-11-21STANDARD
LABELING; LabelingSUPPL4AP2005-03-31STANDARD
LABELING; LabelingSUPPL5AP2005-03-31STANDARD
LABELING; LabelingSUPPL6AP2005-07-08STANDARD
LABELING; LabelingSUPPL7AP2007-01-22STANDARD
LABELING; LabelingSUPPL8AP2006-03-07STANDARD
LABELING; LabelingSUPPL9AP2006-10-23STANDARD
LABELING; LabelingSUPPL10AP2006-10-23STANDARD
EFFICACY; EfficacySUPPL11AP2008-01-07UNKNOWN
LABELING; LabelingSUPPL12AP2007-10-18STANDARD
LABELING; LabelingSUPPL13AP2008-08-07STANDARD
LABELING; LabelingSUPPL17AP2010-02-01UNKNOWN
EFFICACY; EfficacySUPPL20AP2011-10-06STANDARD
EFFICACY; EfficacySUPPL21AP2011-10-06STANDARD
EFFICACY; EfficacySUPPL22AP2013-10-10STANDARD
LABELING; LabelingSUPPL23AP2014-04-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2015-09-01
LABELING; LabelingSUPPL26AP2015-09-16STANDARD
LABELING; LabelingSUPPL27AP2016-04-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2016-07-12
LABELING; LabelingSUPPL29AP2017-05-05STANDARD
EFFICACY; EfficacySUPPL30AP2018-02-15PRIORITY

Submissions Property Types

ORIG1Null31
SUPPL17Null7
SUPPL20Null6
SUPPL21Null7
SUPPL22Null7
SUPPL23Null15
SUPPL25Null0
SUPPL26Null6
SUPPL27Null6
SUPPL28Null0
SUPPL29Null15
SUPPL30Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB1
004PrescriptionAB

CDER Filings

LILLY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21368
            [companyName] => LILLY
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIALIS","activeIngredients":"TADALAFIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CIALIS","activeIngredients":"TADALAFIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CIALIS","activeIngredients":"TADALAFIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CIALIS","activeIngredients":"TADALAFIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/15\/2018","submission":"SUPPL-30","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021368s030lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2017","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021368s029lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2016","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021368s027lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2015","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021368s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2014","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021368s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2013","submission":"SUPPL-22","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021368s022lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2011","submission":"SUPPL-21","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021368s20s21lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2011","submission":"SUPPL-20","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021368s20s21lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2010","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021368s017lbl.pdf\"}]","notes":""},{"actionDate":"01\/07\/2008","submission":"SUPPL-11","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021368s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2007","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021368s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2007","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021368s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2006","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021368s009,s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2006","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021368s009,s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2006","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021368s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2005","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021368s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2005","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021368s004,005lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2005","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021368s004,005lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021368lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CIALIS","submission":"TADALAFIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CIALIS","submission":"TADALAFIL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CIALIS","submission":"TADALAFIL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CIALIS","submission":"TADALAFIL","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-02-15
        )

)
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