ANDA 201402

PERRIGO UK FINCO

FDA Drug Application

Application #201402

Documents

• Letter: 2012-08-17

Application Sponsors

ANDA 201402

PERRIGO UK FINCO

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

0.05%

0

CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE

FDA Submissions

	ORIG	1	AP	2012-08-14
LABELING; Labeling	SUPPL	2	AP	2019-09-06	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-09-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	13	Null	7

TE Codes

001

Prescription

AB2

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201402
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/14\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201402Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/06\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/06\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-06
        )

)