LANNETT CO INC FDA Approval ANDA 088877

ANDA 088877

LANNETT CO INC

FDA Drug Application

Application #088877

Application Sponsors

ANDA 088877LANNETT CO INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**0BENZTROPINE MESYLATEBENZTROPINE MESYLATE

FDA Submissions

ORIG1AP1985-04-11
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1985-12-19
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1985-12-19
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1986-04-29
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1986-04-29
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1988-12-29
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1988-12-29
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1988-12-29
LABELING; LabelingSUPPL12AP1991-06-12
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1994-05-27
LABELING; LabelingSUPPL15AP1991-08-28
LABELING; LabelingSUPPL16AP1993-09-27
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1998-07-02
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1997-11-26
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1997-11-26
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1998-07-02
LABELING; LabelingSUPPL22AP1998-02-27
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2000-07-26
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2000-11-30
LABELING; LabelingSUPPL25AP2002-05-28

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL13Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL23Null0
SUPPL24Null0

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88877
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENZTROPINE MESYLATE","submission":"BENZTROPINE MESYLATE","actionType":"0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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