TARO FDA Approval ANDA 208683

ANDA 208683

TARO

FDA Drug Application

Application #208683

Application Sponsors

ANDA 208683TARO

Marketing Status

Discontinued001

Application Products

001GEL;TOPICAL3.75%;EQ 1.2% BASE0CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2018-06-05STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

TARO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208683
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"3.75%;EQ 1.2% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-05
        )

)

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