ZYDUS FDA Approval ANDA 215210

ANDA 215210

ZYDUS

FDA Drug Application

Application #215210

Application Sponsors

ANDA 215210ZYDUS

Marketing Status

Prescription001

Application Products

001CREAM;TOPICAL1%0IVERMECTINIVERMECTIN

FDA Submissions

UNKNOWN; ORIG1AP2022-08-02STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215210
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"IVERMECTIN","activeIngredients":"IVERMECTIN","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-02
        )

)

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