ANDA 078194

SUN PHARM INDS INC

FDA Drug Application

Application #078194

Documents

• Other Important Information from FDA: 2007-07-05

Application Sponsors

ANDA 078194

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	EQ 10MG BASE	0	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 20MG BASE	0	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE
003	TABLET;ORAL	EQ 30MG BASE	0	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE
004	TABLET;ORAL	EQ 40MG BASE	0	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-06-29
LABELING; Labeling	SUPPL	2	AP	2008-05-29
LABELING; Labeling	SUPPL	4	AP	2008-12-15
LABELING; Labeling	SUPPL	6	AP	2009-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2017-07-14	UNKNOWN
LABELING; Labeling	SUPPL	13	AP	2017-07-14	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-07-14	STANDARD

Submissions Property Types

SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	15

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78194
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PAROXETINE HYDROCHLORIDE","submission":"PAROXETINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PAROXETINE HYDROCHLORIDE","submission":"PAROXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PAROXETINE HYDROCHLORIDE","submission":"PAROXETINE HYDROCHLORIDE","actionType":"EQ 30MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PAROXETINE HYDROCHLORIDE","submission":"PAROXETINE HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)