ANDA 212955

PURDUE PHARMA LP

FDA Drug Application

Application #212955

Documents

• Letter: 2022-08-04

Application Sponsors

ANDA 212955

PURDUE PHARMA LP

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

EQ 2MG BASE/2ML (EQ 1MG BASE/ML)

0

NALMEFENE HYDROCHLORIDE

NALMEFENE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

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
        )

)