ADAMIS PHARMS CORP FDA Approval NDA 212854

NDA 212854

ADAMIS PHARMS CORP

FDA Drug Application

Application #212854

Documents

Label2021-10-18
Letter2021-10-19

Application Sponsors

NDA 212854ADAMIS PHARMS CORP

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION5MG/0.5ML0ZIMHINALOXONE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-10-15STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

ADAMIS PHARMS CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212854
            [companyName] => ADAMIS PHARMS CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZIMHI","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"5MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/15\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212854s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212854s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-15
        )

)

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