ANDA 079094

ACTAVIS LABS FL INC

FDA Drug Application

Application #079094

Application Sponsors

ANDA 079094

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

150MG

0

BUPROPION HYDROCHLORIDE

BUPROPION HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-03-24
LABELING; Labeling	SUPPL	5	AP	2009-11-16
REMS; REMS	SUPPL	8	AP	2010-04-27
LABELING; Labeling	SUPPL	11	AP	2012-04-18
LABELING; Labeling	SUPPL	12	AP	2013-08-16	STANDARD
LABELING; Labeling	SUPPL	16	AP	2015-06-14	STANDARD
LABELING; Labeling	SUPPL	20	AP	2015-06-14	STANDARD
LABELING; Labeling	SUPPL	21	AP	2015-06-14	STANDARD
LABELING; Labeling	SUPPL	24	AP	2017-06-30	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	16	Null	7
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	24	Null	7

TE Codes

001

Prescription

AB2

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79094
            [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":"Yes"}]
            [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
        )

)