INVAGEN PHARMS FDA Approval ANDA 207389

ANDA 207389

INVAGEN PHARMS

FDA Drug Application

Application #207389

Application Sponsors

ANDA 207389INVAGEN PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL75MG0BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE
002TABLET;ORAL100MG0BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-09-18STANDARD
LABELING; LabelingSUPPL5AP2020-10-29STANDARD

Submissions Property Types

ORIG1Null7
SUPPL5Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

INVAGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207389
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/29\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-29
        )

)

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