ANDA 200216

SUN PHARM

FDA Drug Application

Application #200216

Application Sponsors

ANDA 200216

SUN PHARM

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

150MG

0

BUPROPION HYDROCHLORIDE

BUPROPION HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2020-11-30
LABELING; Labeling	SUPPL	2	AP	2022-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7

TE Codes

001

Prescription

AB3

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
        )

)