LANNETT CO INC FDA Approval ANDA 204171

ANDA 204171

LANNETT CO INC

FDA Drug Application

Application #204171

Application Sponsors

ANDA 204171LANNETT CO INC

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL1MG/ML0ARIPIPRAZOLEARIPIPRAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2015-08-14
LABELING; LabelingSUPPL2AP2017-02-23STANDARD
LABELING; LabelingSUPPL3AP2019-12-06STANDARD
LABELING; LabelingSUPPL4AP2020-02-05STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL3Null7
SUPPL4Null7

TE Codes

001PrescriptionAA

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204171
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/14\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/05\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/06\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/18\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-05
        )

)

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