ANDA 091539

WATSON LABS INC

FDA Drug Application

Application #091539

Application Sponsors

ANDA 091539

WATSON LABS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	12.5MG;150MG	0	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN
002	TABLET;ORAL	12.5MG;300MG	0	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN

FDA Submissions

	ORIG	1	AP	2012-10-22
	ORIG	2	TA	2012-10-22

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	1

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91539
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; IRBESARTAN","actionType":"12.5MG;150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; IRBESARTAN","actionType":"12.5MG;300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)