GRANULES FDA Approval ANDA 215568

ANDA 215568

GRANULES

FDA Drug Application

Application #215568

Application Sponsors

ANDA 215568GRANULES

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL150MG0BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL300MG0BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-02STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB3
002PrescriptionAB3

CDER Filings

GRANULES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215568
            [companyName] => GRANULES
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-02
        )

)

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