ANDA 078626

MYLAN PHARMS INC

FDA Drug Application

Application #078626

Documents

• Other Important Information from FDA: 2008-02-28

Application Sponsors

ANDA 078626

MYLAN PHARMS INC

Marketing Status

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

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

FDA Submissions

	ORIG	1	AP	2008-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-07-29
LABELING; Labeling	SUPPL	3	AP	2012-04-26
LABELING; Labeling	SUPPL	5	AP	2014-06-02	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-01-05	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

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	9	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	7

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78626
            [companyName] => MYLAN PHARMS INC
            [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"}]
            [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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)