ANDA 210319

MEDLEY PHARMS

FDA Drug Application

Application #210319

Application Sponsors

ANDA 210319

MEDLEY PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

2MG/ML

0

MEMANTINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-31

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

MEDLEY PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210319
            [companyName] => MEDLEY PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"2MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/31\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-31
        )

)