AMICI FDA Approval ANDA 215209

ANDA 215209

AMICI

FDA Drug Application

Application #215209

Application Sponsors

ANDA 215209AMICI

Marketing Status

Prescription001

Application Products

001ELIXIR;ORAL0.05MG/ML0DIGOXINDIGOXIN

FDA Submissions

UNKNOWN; ORIG1AP2022-03-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

AMICI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215209
            [companyName] => AMICI
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.05MG\/ML","dosageForm":"ELIXIR;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-11
        )

)

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