ANDA 206805

INGENUS PHARMS LLC

FDA Drug Application

Application #206805

Application Sponsors

ANDA 206805

INGENUS PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

0.05%

0

CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-31

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB1

CDER Filings

INGENUS PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206805
            [companyName] => INGENUS PHARMS LLC
            [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":"07\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/06\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-06
        )

)