ANDA 079095

ACTAVIS LABS FL INC

FDA Drug Application

Application #079095

Application Sponsors

ANDA 079095

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	100MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	150MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	200MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-03-24
LABELING; Labeling	SUPPL	4	AP	2009-11-16
REMS; REMS	SUPPL	7	AP	2010-04-27
LABELING; Labeling	SUPPL	9	AP	2010-08-18
LABELING; Labeling	SUPPL	11	AP	2012-04-23
LABELING; Labeling	SUPPL	13	AP	2014-11-20	STANDARD
LABELING; Labeling	SUPPL	16	AP	2014-11-20	STANDARD
LABELING; Labeling	SUPPL	20	AP	2015-06-14	STANDARD
LABELING; Labeling	SUPPL	21	AP	2015-06-14	STANDARD
LABELING; Labeling	SUPPL	26	AP	2020-12-23	STANDARD
LABELING; Labeling	SUPPL	30	AP	2020-12-23	STANDARD
LABELING; Labeling	SUPPL	33	AP	2020-12-23	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	11	Null	15
SUPPL	13	Null	7
SUPPL	16	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	7
SUPPL	26	Null	15
SUPPL	30	Null	7
SUPPL	33	Null	15

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79095
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUPROPION HYDROCHLORIDE","submission":"BUPROPION HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"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":"200MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)