NDA 214916

CARA THERAPEUTICS INC

FDA Drug Application

Application #214916

Documents

• Label: 2021-08-24
• Letter: 2021-08-25
• Review: 2021-09-20

Application Sponsors

NDA 214916

CARA THERAPEUTICS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

65MCG/1.3ML (50MCG/ML)

2

KORSUVA

DIFELIKEFALIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-08-23

PRIORITY

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

TBD

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
        )

)