ANDA 091158

INVAGEN PHARMS

FDA Drug Application

Application #091158

Application Sponsors

ANDA 091158

INVAGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

100MG

0

ORPHENADRINE CITRATE

ORPHENADRINE CITRATE

FDA Submissions

ORIG

1

AP

2012-07-27

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91158
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORPHENADRINE CITRATE","activeIngredients":"ORPHENADRINE CITRATE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ORPHENADRINE CITRATE","submission":"ORPHENADRINE CITRATE","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)