Documents
Application Sponsors
Marketing Status
Application Products
001 | POWDER;INTRAVENOUS | 110MG/VIAL | 1 | ARTESUNATE | ARTESUNATE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-05-26 | PRIORITY |
Submissions Property Types
CDER Filings
AMIVAS
cder:Array
(
[0] => Array
(
[ApplNo] => 213036
[companyName] => AMIVAS
[docInserts] => ["",""]
[products] => [{"drugName":"ARTESUNATE","activeIngredients":"ARTESUNATE","strength":"110MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/26\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213036s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/26\/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\\\/213036s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213036Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-05-26
)
)