ANDA 204054

NEXGEN PHARMA

FDA Drug Application

Application #204054

Application Sponsors

ANDA 204054

NEXGEN PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

2.5MG

0

MECAMYLAMINE HYDROCHLORIDE

MECAMYLAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2013-03-19

Submissions Property Types

ORIG

1

Null

1

CDER Filings

LGM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204054
            [companyName] => LGM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECAMYLAMINE HYDROCHLORIDE","activeIngredients":"MECAMYLAMINE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/19\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-03-19
        )

)