AM REGENT FDA Approval ANDA 216324

ANDA 216324

AM REGENT

FDA Drug Application

Application #216324

Documents

Letter2023-01-10

Application Sponsors

ANDA 216324AM REGENT

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 0.4MG COPPER/ML0CUPRIC SULFATECUPRIC SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2022-12-16STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216324
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CUPRIC SULFATE","activeIngredients":"CUPRIC SULFATE","strength":"EQ 0.4MG COPPER\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-16
        )

)

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