CUSTOPHARM INC FDA Approval ANDA 212416

ANDA 212416

CUSTOPHARM INC

FDA Drug Application

Application #212416

Documents

Letter2021-06-15

Application Sponsors

ANDA 212416CUSTOPHARM INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION200 IU/ML0CALCITONIN-SALMONCALCITONIN SALMON

FDA Submissions

UNKNOWN; ORIG1AP2021-05-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

CUSTOPHARM INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212416
            [companyName] => CUSTOPHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCITONIN-SALMON","activeIngredients":"CALCITONIN SALMON","strength":"200 IU\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-14
        )

)

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