NDA 022332

ELI LILLY CO

FDA Drug Application

Application #022332

Documents

• Letter: 2009-05-29
• Letter: 2011-02-14
• Letter: 2015-04-03
• Label: 2009-05-25
• Label: 2014-05-02
• Label: 2015-04-07
• Review: 2009-08-03
• Letter: 2013-11-25
• Letter: 2014-04-30
• Label: 2011-02-09
• Label: 2013-11-22
• Letter: 2017-05-09
• Label: 2017-05-09
• Letter: 2020-09-16
• Label: 2020-09-21

Application Sponsors

NDA 022332

ELI LILLY CO

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

20MG

1

ADCIRCA

TADALAFIL

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)	ORIG	1	AP	2009-05-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	2011-02-08	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2013-11-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-04-29	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-04-02	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-05-05	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-09-15	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	6
SUPPL	5	Null	15
SUPPL	6	Null	6
SUPPL	7	Null	6
SUPPL	9	Null	7
SUPPL	11	Null	15

TE Codes

001

Prescription

AB2

CDER Filings

ELI LILLY CO

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(
    [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
        )

)