LANNETT CO INC FDA Approval ANDA 078281

ANDA 078281

LANNETT CO INC

FDA Drug Application

Application #078281

Application Sponsors

ANDA 078281LANNETT CO INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, DELAYED RELEASE;ORALEQ 20MG BASE0PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM
002TABLET, DELAYED RELEASE;ORALEQ 40MG BASE0PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM

FDA Submissions

ORIG1AP2011-01-20
LABELING; LabelingSUPPL6AP2014-08-05
LABELING; LabelingSUPPL8AP2012-01-17
LABELING; LabelingSUPPL10AP2012-01-17
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2012-05-18
LABELING; LabelingSUPPL12AP2013-05-24STANDARD
LABELING; LabelingSUPPL13AP2013-05-24STANDARD
LABELING; LabelingSUPPL15AP2013-12-10STANDARD
LABELING; LabelingSUPPL16AP2014-12-10STANDARD
LABELING; LabelingSUPPL17AP2015-04-08STANDARD
LABELING; LabelingSUPPL19AP2020-01-03STANDARD
LABELING; LabelingSUPPL21AP2020-01-03STANDARD
LABELING; LabelingSUPPL22AP2020-01-03STANDARD
LABELING; LabelingSUPPL23AP2020-01-03STANDARD
LABELING; LabelingSUPPL24AP2020-01-03STANDARD
LABELING; LabelingSUPPL29AP2022-01-21STANDARD
LABELING; LabelingSUPPL30AP2022-01-21STANDARD
LABELING; LabelingSUPPL32AP2022-06-09STANDARD

Submissions Property Types

ORIG1Null7
SUPPL6Null8
SUPPL8Null15
SUPPL10Null15
SUPPL11Null15
SUPPL12Null15
SUPPL13Null15
SUPPL15Null15
SUPPL16Null7
SUPPL17Null7
SUPPL19Null7
SUPPL21Null7
SUPPL22Null7
SUPPL23Null15
SUPPL24Null15
SUPPL29Null31
SUPPL30Null15
SUPPL32Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78281
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PANTOPRAZOLE SODIUM","submission":"PANTOPRAZOLE SODIUM","actionType":"EQ 20MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PANTOPRAZOLE SODIUM","submission":"PANTOPRAZOLE SODIUM","actionType":"EQ 40MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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