ENCUBE FDA Approval ANDA 212438

ANDA 212438

ENCUBE

FDA Drug Application

Application #212438

Application Sponsors

ANDA 212438ENCUBE

Marketing Status

Prescription001

Application Products

001GEL;TOPICALEQ 1% BASE0CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ENCUBE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212438
            [companyName] => ENCUBE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 1% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-11
        )

)

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