LANNETT CO INC FDA Approval ANDA 201522

ANDA 201522

LANNETT CO INC

FDA Drug Application

Application #201522

Documents

Letter2012-08-06

Application Sponsors

ANDA 201522LANNETT CO INC

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 10MG BASE0MONTELUKAST SODIUMMONTELUKAST SODIUM

FDA Submissions

N/A; Not ApplicableORIG1AP2012-08-03
LABELING; LabelingSUPPL2AP2013-01-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2016-01-06UNKNOWN
LABELING; LabelingSUPPL4AP2013-08-22STANDARD
LABELING; LabelingSUPPL6AP2016-06-02STANDARD
LABELING; LabelingSUPPL9AP2018-07-23STANDARD
LABELING; LabelingSUPPL10AP2020-10-08STANDARD
LABELING; LabelingSUPPL12AP2020-10-08STANDARD
LABELING; LabelingSUPPL14AP2020-10-08STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null7
SUPPL4Null15
SUPPL6Null7
SUPPL9Null15
SUPPL10Null15
SUPPL12Null15
SUPPL14Null15

TE Codes

001PrescriptionAB

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201522
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201522Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/23\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/02\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/22\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/06\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/31\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-07-23
        )

)

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