ANDA 200302

TARO

FDA Drug Application

Application #200302

Application Sponsors

ANDA 200302

TARO

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.05%

0

CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE

FDA Submissions

	ORIG	1	AP	2012-07-02
LABELING; Labeling	SUPPL	2	AP	2019-09-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200302
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/02\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/06\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-06
        )

)