ANDA 079082

LANNETT CO INC

FDA Drug Application

Application #079082

Application Sponsors

ANDA 079082

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

300MG

0

URSODIOL

URSODIOL

FDA Submissions

ORIG

1

AP

2008-12-15

TE Codes

001

Prescription

AB

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79082
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"URSODIOL","activeIngredients":"URSODIOL","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"URSODIOL","submission":"URSODIOL","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)