LANNETT CO INC FDA Approval ANDA 077421

ANDA 077421

LANNETT CO INC

FDA Drug Application

Application #077421

Documents

Letter2006-07-13

Application Sponsors

ANDA 077421LANNETT CO INC

Marketing Status

Over-the-counter001

Application Products

001SYRUP;ORAL1MG/ML0LORATADINELORATADINE

FDA Submissions

ORIG1AP2006-06-29
LABELING; LabelingSUPPL4AP2014-08-12
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2014-11-07

Submissions Property Types

SUPPL4Null7
SUPPL8Null15

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77421
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"1MG\/ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORATADINE","submission":"LORATADINE","actionType":"1MG\/ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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