LANNETT CO INC FDA Approval ANDA 091188

ANDA 091188

LANNETT CO INC

FDA Drug Application

Application #091188

Application Sponsors

ANDA 091188LANNETT CO INC

Marketing Status

Prescription001

Application Products

001ELIXIR;ORAL0.5MG/5ML0DEXAMETHASONEDEXAMETHASONE

FDA Submissions

ORIG1AP2011-05-11

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91188
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"0.5MG\/5ML","dosageForm":"ELIXIR;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXAMETHASONE","submission":"DEXAMETHASONE","actionType":"0.5MG\/5ML","submissionClassification":"ELIXIR;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.