ANDA 077415

IMPAX LABS

FDA Drug Application

Application #077415

Documents

• Review: 2013-05-14
• Letter: 2007-02-23
• Review: 2011-08-09
• Review: 2013-05-14

Application Sponsors

ANDA 077415

IMPAX LABS

Marketing Status

• Prescription: 001
• Discontinued: 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	2006-12-15
LABELING; Labeling	SUPPL	2	AP	2007-09-17
LABELING; Labeling	SUPPL	3	AP	2007-09-17
LABELING; Labeling	SUPPL	5	AP	2008-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2008-11-26
LABELING; Labeling	SUPPL	7	AP	2008-11-26
LABELING; Labeling	SUPPL	10	AP	2009-12-15
LABELING; Labeling	SUPPL	13	AP	2010-01-22
REMS; REMS	SUPPL	15	AP	2010-05-13
LABELING; Labeling	SUPPL	17	AP	2011-08-30
LABELING; Labeling	SUPPL	18	AP	2012-03-29
LABELING; Labeling	SUPPL	25	AP	2014-12-01	STANDARD
LABELING; Labeling	SUPPL	29	AP	2017-09-26	STANDARD
LABELING; Labeling	SUPPL	32	AP	2017-09-26	STANDARD
LABELING; Labeling	SUPPL	33	AP	2017-09-26	STANDARD
LABELING; Labeling	SUPPL	36	AP	2020-08-07	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	10	Null	7
SUPPL	13	Null	7
SUPPL	17	Null	15
SUPPL	18	Null	15
SUPPL	25	Null	15
SUPPL	29	Null	15
SUPPL	32	Null	15
SUPPL	33	Null	15
SUPPL	36	Null	7

TE Codes

001

Prescription

AB3

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77415
            [companyName] => IMPAX LABS
            [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":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [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":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)