AMNEAL FDA Approval ANDA 214895

ANDA 214895

AMNEAL

FDA Drug Application

Application #214895

Application Sponsors

ANDA 214895AMNEAL

Marketing Status

Prescription001

Application Products

001SHAMPOO;TOPICAL0.05%0CLOBETASOL PROPIONATECLOBETASOL PROPIONATE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214895
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"SHAMPOO;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-14
        )

)

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