LANNETT CO INC FDA Approval ANDA 201961

ANDA 201961

LANNETT CO INC

FDA Drug Application

Application #201961

Application Sponsors

ANDA 201961LANNETT CO INC

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL37.5MG0PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE

FDA Submissions

N/A; Not ApplicableORIG1AP2011-07-20
LABELING; LabelingSUPPL2AP2012-04-20
LABELING; LabelingSUPPL3AP2012-12-05STANDARD
LABELING; LabelingSUPPL7AP2017-05-31STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null15
SUPPL7Null7

TE Codes

001PrescriptionAA

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201961
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"37.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/20\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/31\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/05\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/20\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/14\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-05-31
        )

)

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