ANDA 209019

PERRIGO UK FINCO

FDA Drug Application

Application #209019

Documents

• Letter: 2017-11-08
• Letter: 2019-02-21

Application Sponsors

ANDA 209019

PERRIGO UK FINCO

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.05%

0

INGENOL MEBUTATE

INGENOL MEBUTATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-03-05	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-03-19	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209019
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"INGENOL MEBUTATE","activeIngredients":"INGENOL MEBUTATE","strength":"0.05%","dosageForm":"GEL;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209019Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209019Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/26\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-26
        )

)