Documents
Application Sponsors
NDA 214916 | CARA THERAPEUTICS INC | |
Marketing Status
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
TE Codes
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
)
)