HERON THERAPS INC FDA Approval NDA 216457

NDA 216457

HERON THERAPS INC

FDA Drug Application

Application #216457

Documents

Letter2022-09-19
Label2022-09-20

Application Sponsors

NDA 216457HERON THERAPS INC

Marketing Status

Prescription001

Application Products

001EMULSION;INTRAVENOUS32MG/4.4ML0APONVIEAPREPITANT

FDA Submissions

TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not ConsolidatedORIG1AP2022-09-16STANDARD

Submissions Property Types

ORIG1Null40

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
        )

)

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