ANDA 077284

ANCHEN PHARMS

FDA Drug Application

Application #077284

Documents

• Letter: 2006-12-28
• Label: 2007-01-19
• Review: 2012-03-28

Application Sponsors

ANDA 077284

ANCHEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	150MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	300MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-12-14
LABELING; Labeling	SUPPL	8	AP	2007-09-17
LABELING; Labeling	SUPPL	11	AP	2011-01-20
LABELING; Labeling	SUPPL	17	AP	2009-12-15
LABELING; Labeling	SUPPL	18	AP	2011-01-25
REMS; REMS	SUPPL	20	AP	2010-11-19
LABELING; Labeling	SUPPL	22	AP	2011-08-30
LABELING; Labeling	SUPPL	23	AP	2011-10-31
LABELING; Labeling	SUPPL	30	AP	2014-12-13	STANDARD
LABELING; Labeling	SUPPL	33	AP	2017-08-25	STANDARD
LABELING; Labeling	SUPPL	36	AP	2017-08-25	STANDARD
LABELING; Labeling	SUPPL	39	AP	2017-08-25	STANDARD
LABELING; Labeling	SUPPL	42	AP	2019-06-12	STANDARD

Submissions Property Types

SUPPL	11	Null	7
SUPPL	17	Null	7
SUPPL	22	Null	15
SUPPL	23	Null	15
SUPPL	30	Null	31
SUPPL	33	Null	7
SUPPL	36	Null	15
SUPPL	39	Null	7
SUPPL	42	Null	7

TE Codes

001	Prescription	AB3
002	Prescription	AB3

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77284
            [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"},{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/14\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/077284lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BUPROPION HYDROCHLORIDE","submission":"BUPROPION HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BUPROPION HYDROCHLORIDE","submission":"BUPROPION HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2006-12-14
        )

)