CELERITY PHARMS FDA Approval NDA 216078

NDA 216078

CELERITY PHARMS

FDA Drug Application

Application #216078

Documents

Letter2022-07-15

Application Sponsors

NDA 216078CELERITY PHARMS

Marketing Status

None (Tentative Approval)001

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1TA2022-07-14STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

CELERITY PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216078
            [companyName] => CELERITY PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/4ML","dosageForm":"SOLUTION;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/14\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216078Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-14
        )

)

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