LANNETT CO INC FDA Approval ANDA 091359

ANDA 091359

LANNETT CO INC

FDA Drug Application

Application #091359

Application Sponsors

ANDA 091359LANNETT CO INC

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL30MG0PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2010-07-16
LABELING; LabelingSUPPL2AP2012-04-19
LABELING; LabelingSUPPL3AP2012-12-05STANDARD
LABELING; LabelingSUPPL6AP2017-05-31STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL3Null7
SUPPL6Null15

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91359
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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