SUN PHARM FDA Approval ANDA 200216

ANDA 200216

SUN PHARM

FDA Drug Application

Application #200216

Application Sponsors

ANDA 200216SUN PHARM

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL150MG0BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE

FDA Submissions

N/A; Not ApplicableORIG1AP2020-11-30

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAB3

CDER Filings

SUN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200216
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-30
        )

)

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