Documents
Application Sponsors
NDA 213170 | LA JOLLA PHARMA | |
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | TA | 2020-05-29 | PRIORITY |
Submissions Property Types
CDER Filings
LA JOLLA PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 213170
[companyName] => LA JOLLA PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"ARTESUNATE","activeIngredients":"ARTESUNATE","strength":"UNKNOWN","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/29\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213170Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-05-29
)
)