ANDA 090956

NEXGEN PHARMA

FDA Drug Application

Application #090956

Application Sponsors

ANDA 090956

NEXGEN PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG;50MG

0

BUTALBITAL AND ACETAMINOPHEN

ACETAMINOPHEN; BUTALBITAL

FDA Submissions

ORIG

1

AP

2011-08-23

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

LGM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90956
            [companyName] => LGM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"300MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTALBITAL AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; BUTALBITAL","actionType":"300MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)