CARA THERAPEUTICS INC FDA Approval NDA 214916

NDA 214916

CARA THERAPEUTICS INC

FDA Drug Application

Application #214916

Documents

Label2021-08-24
Letter2021-08-25
Review2021-09-20

Application Sponsors

NDA 214916CARA THERAPEUTICS INC

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS65MCG/1.3ML (50MCG/ML)2KORSUVADIFELIKEFALIN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-08-23PRIORITY

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionTBD

CDER Filings

CARA THERAPEUTICS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214916
            [companyName] => CARA THERAPEUTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KORSUVA","activeIngredients":"DIFELIKEFALIN","strength":"65MCG\/1.3ML (50MCG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"08\/23\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214916s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214916s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-08-23
        )

)

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