ANDA 077285

WATSON LABS INC

FDA Drug Application

Application #077285

Documents

• Review: 2011-08-09

Application Sponsors

ANDA 077285

WATSON LABS INC

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	2008-08-15
LABELING; Labeling	SUPPL	4	AP	2008-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2008-11-26
LABELING; Labeling	SUPPL	8	AP	2009-12-15
REMS; REMS	SUPPL	14	AP	2010-06-25
LABELING; Labeling	SUPPL	17	AP	2011-10-31
LABELING; Labeling	SUPPL	19	AP	2013-04-30	STANDARD
REMS; REMS	SUPPL	20	AP	2013-03-11
LABELING; Labeling	SUPPL	30	AP	2015-02-25	STANDARD
LABELING; Labeling	SUPPL	32	AP	2015-02-25	STANDARD
LABELING; Labeling	SUPPL	34	AP	2017-06-12	STANDARD
LABELING; Labeling	SUPPL	35	AP	2020-10-07	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	8	Null	7
SUPPL	17	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	30	Null	7
SUPPL	32	Null	15
SUPPL	34	Null	15
SUPPL	35	Null	15

TE Codes

001	Prescription	AB3
002	Prescription	AB3

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77285
            [companyName] => WATSON LABS 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":"Prescription","te":"","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":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)