ANDA 077977

SUN PHARM INDS LTD

FDA Drug Application

Application #077977

Application Sponsors

ANDA 077977

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	EQ 25MG BASE	0	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 50MG BASE	0	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
003	TABLET;ORAL	EQ 100MG BASE	0	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
004	TABLET;ORAL	EQ 150MG BASE	0	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
005	TABLET;ORAL	EQ 200MG BASE	0	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-02-06
LABELING; Labeling	SUPPL	2	AP	2008-01-09
LABELING; Labeling	SUPPL	3	AP	2008-09-15
LABELING; Labeling	SUPPL	4	AP	2009-03-23
LABELING; Labeling	SUPPL	6	AP	2009-03-23
LABELING; Labeling	SUPPL	7	AP	2009-09-30
LABELING; Labeling	SUPPL	8	AP	2011-09-29
LABELING; Labeling	SUPPL	9	AP	2014-12-12	STANDARD
LABELING; Labeling	SUPPL	10	AP	2014-12-12	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-01-20	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-12-23	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-08-30	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77977
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 200MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)