GENZUM FDA Approval ANDA 210038

ANDA 210038

GENZUM

FDA Drug Application

Application #210038

Application Sponsors

ANDA 210038GENZUM

Marketing Status

Prescription001

Application Products

001CREAM;TOPICAL2.0%0NAFTIFINE HYDROCHLORIDENAFTIFINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

GENZUM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210038
            [companyName] => GENZUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAFTIFINE HYDROCHLORIDE","activeIngredients":"NAFTIFINE HYDROCHLORIDE","strength":"2.0%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-22
        )

)

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