ACCORD HLTHCARE FDA Approval ANDA 216624

ANDA 216624

ACCORD HLTHCARE

FDA Drug Application

Application #216624

Application Sponsors

ANDA 216624ACCORD HLTHCARE

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION0.4MG/ML0NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE
002INJECTABLE;INJECTION1MG/ML0NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216624
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALOXONE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"0.4MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NALOXONE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-26
        )

)

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