ANDA 209955

APOTEX

FDA Drug Application

Application #209955

Application Sponsors

ANDA 209955

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

2MG/ML

0

MEMANTINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-02-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209955
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"2MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-09
        )

)