ANDA 078243

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078243

Application Sponsors

ANDA 078243

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 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
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2015-06-10
LABELING; Labeling	SUPPL	4	AP	2011-03-22
LABELING; Labeling	SUPPL	6	AP	2012-01-03
LABELING; Labeling	SUPPL	7	AP	2012-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2012-07-20
LABELING; Labeling	SUPPL	12	AP	2013-03-19	STANDARD
LABELING; Labeling	SUPPL	14	AP	2014-09-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2014-09-21	STANDARD
LABELING; Labeling	SUPPL	19	AP	2015-06-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	15
SUPPL	12	Null	15
SUPPL	14	Null	7
SUPPL	16	Null	7
SUPPL	19	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78243
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)