INGENUS PHARMS LLC FDA Approval NDA 212501

NDA 212501

INGENUS PHARMS LLC

FDA Drug Application

Application #212501

Documents

Letter2020-07-31
Label2020-08-03

Application Sponsors

NDA 212501INGENUS PHARMS LLC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION500MG/2.5ML0CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE
002INJECTABLE;INJECTION1G/5ML0CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2020-07-30STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

INGENUS PHARMS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212501
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"500MG\/2.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"1G\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/30\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212501s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212501s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212501Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-30
        )

)

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