LANNETT CO INC FDA Approval ANDA 077960

ANDA 077960

LANNETT CO INC

FDA Drug Application

Application #077960

Documents

Letter2006-10-18

Application Sponsors

ANDA 077960LANNETT CO INC

Marketing Status

Prescription001

Application Products

001SYRUP;ORAL250MG/5ML0VALPROIC ACIDVALPROIC ACID

FDA Submissions

ORIG1AP2006-10-13
LABELING; LabelingSUPPL4AP2010-01-20
LABELING; LabelingSUPPL6AP2014-12-15
LABELING; LabelingSUPPL9AP2014-12-15STANDARD
LABELING; LabelingSUPPL10AP2014-12-15STANDARD
LABELING; LabelingSUPPL11AP2014-12-15STANDARD
LABELING; LabelingSUPPL12AP2014-12-15STANDARD
LABELING; LabelingSUPPL13AP2014-12-15STANDARD
LABELING; LabelingSUPPL14AP2016-04-28STANDARD
LABELING; LabelingSUPPL15AP2016-04-28STANDARD
LABELING; LabelingSUPPL16AP2016-04-28STANDARD
LABELING; LabelingSUPPL17AP2016-04-28STANDARD
LABELING; LabelingSUPPL18AP2016-04-28STANDARD
LABELING; LabelingSUPPL19AP2016-04-28STANDARD
LABELING; LabelingSUPPL20AP2020-10-14STANDARD
LABELING; LabelingSUPPL21AP2020-10-14STANDARD
LABELING; LabelingSUPPL22AP2020-10-14STANDARD
LABELING; LabelingSUPPL24AP2020-10-14STANDARD
LABELING; LabelingSUPPL26AP2020-10-14STANDARD

Submissions Property Types

SUPPL4Null7
SUPPL6Null15
SUPPL9Null7
SUPPL10Null7
SUPPL11Null7
SUPPL12Null7
SUPPL13Null7
SUPPL14Null15
SUPPL15Null15
SUPPL16Null15
SUPPL17Null7
SUPPL18Null7
SUPPL19Null15
SUPPL20Null15
SUPPL21Null15
SUPPL22Null7
SUPPL24Null15
SUPPL26Null15

TE Codes

001PrescriptionAA

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77960
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALPROIC ACID","activeIngredients":"VALPROIC ACID","strength":"250MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALPROIC ACID","submission":"VALPROIC ACID","actionType":"250MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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