Documents
Application Sponsors
NDA 216457 | HERON THERAPS INC | |
Marketing Status
Application Products
001 | EMULSION;INTRAVENOUS | 32MG/4.4ML | 0 | APONVIE | APREPITANT |
FDA Submissions
TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated | ORIG | 1 | AP | 2022-09-16 | STANDARD |
Submissions Property Types
CDER Filings
HERON THERAPS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 216457
[companyName] => HERON THERAPS INC
[docInserts] => ["",""]
[products] => [{"drugName":"APONVIE","activeIngredients":"APREPITANT","strength":"32MG\/4.4ML","dosageForm":"EMULSION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"09\/16\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216457s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216457s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216457Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2022-09-16
)
)