ANDA 077715

ACTAVIS LABS FL INC

FDA Drug Application

Application #077715

Documents

• Review: 2011-12-16
• Other Important Information from FDA: 2007-06-18

Application Sponsors

ANDA 077715

ACTAVIS LABS FL INC

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	2007-06-13
LABELING; Labeling	SUPPL	2	AP	2008-07-09
LABELING; Labeling	SUPPL	6	AP	2008-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2008-11-26
LABELING; Labeling	SUPPL	15	AP	2009-11-09
LABELING; Labeling	SUPPL	18	AP	2010-02-04
REMS; REMS	SUPPL	20	AP	2010-04-27
LABELING; Labeling	SUPPL	22	AP	2010-08-30
LABELING; Labeling	SUPPL	23	AP	2012-04-23
LABELING; Labeling	SUPPL	31	AP	2014-12-20	STANDARD
LABELING; Labeling	SUPPL	34	AP	2020-10-16	STANDARD
LABELING; Labeling	SUPPL	38	AP	2020-10-16	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	7	Null	0
SUPPL	15	Null	7
SUPPL	18	Null	7
SUPPL	23	Null	15
SUPPL	31	Null	7
SUPPL	34	Null	15
SUPPL	38	Null	15

TE Codes

001

Prescription

AB3

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77715
            [companyName] => ACTAVIS LABS FL INC
            [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
        )

)