ANDA 091286

TRIS PHARMA INC

FDA Drug Application

Application #091286

Application Sponsors

ANDA 091286

TRIS PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

250MG/5ML

0

GABAPENTIN

GABAPENTIN

FDA Submissions

ORIG

1

AP

2016-03-14

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AA

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91286
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"250MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"250MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)