NDA 209862

KALEO INC

FDA Drug Application

Application #209862

Documents

• Letter: 2016-10-20
• Label: 2016-10-27
• Review: 2016-12-13

Application Sponsors

NDA 209862

KALEO INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

2MG/0.4ML (2MG/0.4ML)

1

EVZIO (AUTOINJECTOR)

NALOXONE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2016-10-19

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

KALEO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209862
            [companyName] => KALEO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVZIO (AUTOINJECTOR)","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"2MG\/0.4ML (2MG\/0.4ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/19\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/209862lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/19\/2016","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\\\/2016\\\/209862lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/209862Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/209862Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-10-19
        )

)