ANDA 077106

CADILA

FDA Drug Application

Application #077106

Application Sponsors

ANDA 077106

CADILA

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	2007-02-06
LABELING; Labeling	SUPPL	2	AP	2008-03-10
LABELING; Labeling	SUPPL	3	AP	2008-09-24
LABELING; Labeling	SUPPL	4	AP	2009-09-28
LABELING; Labeling	SUPPL	5	AP	2012-05-21
LABELING; Labeling	SUPPL	6	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-02-21	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	15

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77106
            [companyName] => CADILA
            [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
        )

)