ANDA 091520

ANCHEN PHARMS

FDA Drug Application

Application #091520

Application Sponsors

ANDA 091520

ANCHEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

150MG

0

BUPROPION HYDROCHLORIDE

BUPROPION HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-06-09
LABELING; Labeling	SUPPL	2	AP	2012-04-23
LABELING; Labeling	SUPPL	5	AP	2013-08-16	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-08-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-08-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	5	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7

TE Codes

001

Prescription

AB2

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91520
            [companyName] => ANCHEN PHARMS
            [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":"BUPROPION HYDROCHLORIDE","submission":"BUPROPION HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)