PURDUE PHARMA LP FDA Approval ANDA 212955

ANDA 212955

PURDUE PHARMA LP

FDA Drug Application

Application #212955

Application Sponsors

ANDA 212955PURDUE PHARMA LP

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEQ 2MG BASE/2ML (EQ 1MG BASE/ML)0NALMEFENE HYDROCHLORIDENALMEFENE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-08STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

PURDUE PHARMA LP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212955
            [companyName] => PURDUE PHARMA LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALMEFENE HYDROCHLORIDE","activeIngredients":"NALMEFENE HYDROCHLORIDE","strength":"EQ 2MG BASE\/2ML (EQ 1MG BASE\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-08
        )

)

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