ANDA 091586

TRIS PHARMA INC

FDA Drug Application

Application #091586

Application Sponsors

ANDA 091586

TRIS PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

80MG/15ML

0

THEOPHYLLINE

THEOPHYLLINE

FDA Submissions

ORIG

1

AP

2012-06-15

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AA

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91586
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"80MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEOPHYLLINE","submission":"THEOPHYLLINE","actionType":"80MG\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)