KALEO INC FDA Approval NDA 215457

NDA 215457

KALEO INC

FDA Drug Application

Application #215457

Documents

Letter2022-03-01
Label2022-03-01
Review2022-04-18

Application Sponsors

NDA 215457KALEO INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION10MG0NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-02-28PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

KALEO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215457
            [companyName] => KALEO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALOXONE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"10MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/28\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215457s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215457s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215457Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-02-28
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.