ANDA 091497

PRINSTON INC

FDA Drug Application

Application #091497

Application Sponsors

ANDA 091497

PRINSTON 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	2011-06-06
LABELING; Labeling	SUPPL	3	AP	2014-12-11	STANDARD
LABELING; Labeling	SUPPL	4	AP	2014-12-11	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-02-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	2017-04-12	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-04-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91497
            [companyName] => PRINSTON 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
        )

)