Documents
Application Sponsors
NDA 213793 | RHYTHM PHARMACEUTICALS INC | |
Marketing Status
Application Products
001 | SOLUTION;SUBCUTANEOUS | 10MG/ML | 2 | IMCIVREE | SETMELANOTIDE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-11-25 | PRIORITY |
Submissions Property Types
TE Codes
CDER Filings
RHYTHM PHARMACEUTICALS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 213793
[companyName] => RHYTHM PHARMACEUTICALS INC
[docInserts] => ["",""]
[products] => [{"drugName":"IMCIVREE","activeIngredients":"SETMELANOTIDE","strength":"10MG\/ML","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213793s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213793s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213793Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-11-25
)
)