INVAGEN PHARMS FDA Approval ANDA 204414

ANDA 204414

INVAGEN PHARMS

FDA Drug Application

Application #204414

Application Sponsors

ANDA 204414INVAGEN PHARMS

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL30MG0PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2014-05-05

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

INVAGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204414
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/05\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/31\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-05-31
        )

)

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