ANDA 091522

NEXGEN PHARMA

FDA Drug Application

Application #091522

Application Sponsors

ANDA 091522

NEXGEN PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1.5MG

0

GLYCOPYRROLATE

GLYCOPYRROLATE

FDA Submissions

ORIG

1

AP

2012-03-12

Submissions Property Types

ORIG

1

Null

15

CDER Filings

NEXGEN PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91522
            [companyName] => NEXGEN PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLYCOPYRROLATE","submission":"GLYCOPYRROLATE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)