AMNEAL FDA Approval ANDA 208766

ANDA 208766

AMNEAL

FDA Drug Application

Application #208766

Application Sponsors

ANDA 208766AMNEAL

Marketing Status

Prescription001

Application Products

001CREAM;TOPICAL5%0ACYCLOVIRACYCLOVIR

FDA Submissions

UNKNOWN; ORIG1AP2020-11-09STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208766
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-09
        )

)

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