ANDA 076711

IMPAX LABS

FDA Drug Application

Application #076711

Documents

• Other Important Information from FDA: 2005-07-28

Application Sponsors

ANDA 076711

IMPAX LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

200MG

0

BUPROPION HYDROCHLORIDE

BUPROPION HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-12-03
LABELING; Labeling	SUPPL	3	AP	2006-02-14
LABELING; Labeling	SUPPL	5	AP	2006-10-05
LABELING; Labeling	SUPPL	7	AP	2008-01-16
LABELING; Labeling	SUPPL	9	AP	2010-01-27
REMS; REMS	SUPPL	11	AP	2010-07-08
LABELING; Labeling	SUPPL	12	AP	2010-08-18
LABELING; Labeling	SUPPL	13	AP	2012-02-21
LABELING; Labeling	SUPPL	14	AP	2012-02-21
LABELING; Labeling	SUPPL	19	AP	2015-09-29	STANDARD
LABELING; Labeling	SUPPL	23	AP	2015-09-29	STANDARD
LABELING; Labeling	SUPPL	24	AP	2015-09-29	STANDARD
LABELING; Labeling	SUPPL	27	AP	2015-09-29	STANDARD
LABELING; Labeling	SUPPL	30	AP	2021-01-04	STANDARD
LABELING; Labeling	SUPPL	31	AP	2021-01-04	STANDARD
LABELING; Labeling	SUPPL	32	AP	2021-01-04	STANDARD
LABELING; Labeling	SUPPL	39	AP	2021-01-04	STANDARD
LABELING; Labeling	SUPPL	40	AP	2021-01-04	STANDARD

Submissions Property Types

SUPPL	9	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	19	Null	7
SUPPL	23	Null	15
SUPPL	24	Null	15
SUPPL	27	Null	7
SUPPL	30	Null	7
SUPPL	31	Null	7
SUPPL	32	Null	7
SUPPL	39	Null	15
SUPPL	40	Null	15

TE Codes

001

Prescription

AB1

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76711
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"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":"200MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)