AUROMEDICS PHARMA FDA Approval NDA 210735

NDA 210735

AUROMEDICS PHARMA

FDA Drug Application

Application #210735

Documents

Letter2021-08-27

Application Sponsors

NDA 210735AUROMEDICS PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUS500MG/2.5ml (200MG/ML)2CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE
002SOLUTION;INTRAVENOUS1GM/5ML (200MG/ML)2CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-08-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionTBD
002PrescriptionTBD

CDER Filings

AUROMEDICS PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210735
            [companyName] => AUROMEDICS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"500MG\/2.5ml (200MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"1GM\/5ML (200MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/210735Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-25
        )

)

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