ANDA 075584

APNAR PHARMA LP

FDA Drug Application

Application #075584

Documents

• Other Important Information from FDA: 2005-07-28
• Letter: 2000-02-07
• Review: 2001-06-07

Application Sponsors

ANDA 075584

APNAR PHARMA LP

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	75MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE
002	TABLET;ORAL	100MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2000-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-01-18
LABELING; Labeling	SUPPL	7	AP	2002-11-05
LABELING; Labeling	SUPPL	9	AP	2004-02-04
LABELING; Labeling	SUPPL	12	AP	2005-06-01
LABELING; Labeling	SUPPL	14	AP	2007-02-08
LABELING; Labeling	SUPPL	19	AP	2007-02-08
LABELING; Labeling	SUPPL	20	AP	2008-01-16
LABELING; Labeling	SUPPL	23	AP	2008-12-19
LABELING; Labeling	SUPPL	24	AP	2007-12-19
LABELING; Labeling	SUPPL	27	AP	2009-11-16
LABELING; Labeling	SUPPL	31	AP	2010-03-04
REMS; REMS	SUPPL	32	AP	2010-07-08
LABELING; Labeling	SUPPL	33	AP	2012-03-27
LABELING; Labeling	SUPPL	34	AP	2012-03-28
LABELING; Labeling	SUPPL	36	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	38	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	41	AP	2015-05-16	STANDARD
LABELING; Labeling	SUPPL	42	AP	2015-05-16	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	27	Null	7
SUPPL	31	Null	7
SUPPL	33	Null	15
SUPPL	34	Null	15
SUPPL	36	Null	7
SUPPL	38	Null	15
SUPPL	41	Null	7
SUPPL	42	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

APNAR PHARMA LP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75584
            [companyName] => APNAR PHARMA LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUPROPION HYDROCHLORIDE","submission":"BUPROPION HYDROCHLORIDE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BUPROPION HYDROCHLORIDE","submission":"BUPROPION HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)