ANDA 090790

APOTEX CORP

FDA Drug Application

Application #090790

Documents

• Review: 2013-02-01

Application Sponsors

ANDA 090790

APOTEX CORP

Marketing Status

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

Application Products

001	TABLET;ORAL	25MG	0	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM
002	TABLET;ORAL	50MG	0	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM
003	TABLET;ORAL	100MG	0	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM

FDA Submissions

	ORIG	1	AP	2010-10-06
LABELING; Labeling	SUPPL	4	AP	2012-12-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-11-05	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-11-05	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-06-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	15

CDER Filings

APOTEX CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90790
            [companyName] => APOTEX CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)