ACCORD HLTHCARE INC FDA Approval NDA 212035

NDA 212035

ACCORD HLTHCARE INC

FDA Drug Application

Application #212035

Documents

Letter2019-03-08
Label2021-06-08
Review2021-11-09

Application Sponsors

NDA 212035ACCORD HLTHCARE INC

Marketing Status

None (Tentative Approval)001

Application Products

001INJECTABLE;INJECTION50MG/50ML (1MG/ML)2ARGATROBANARGATROBAN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1TA2019-02-28STANDARD

Submissions Property Types

ORIG1Null6

TE Codes

001PrescriptionTBD

CDER Filings

ACCORD HLTHCARE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212035
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARGATROBAN","activeIngredients":"ARGATROBAN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2019","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\\\/2019\\\/212035Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-28
        )

)

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