ANDA 091519

WATSON LABS TEVA

FDA Drug Application

Application #091519

Application Sponsors

ANDA 091519

WATSON LABS TEVA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	12.5MG;80MG	0	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN
002	TABLET;ORAL	12.5MG;160MG	0	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN
003	TABLET;ORAL	12.5MG;320MG	0	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN
004	TABLET;ORAL	25MG;160MG	0	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN
005	TABLET;ORAL	25MG;320MG	0	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN

FDA Submissions

ORIG

1

AP

2013-03-21

Submissions Property Types

ORIG

1

Null

15

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91519
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"12.5MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"12.5MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"12.5MG;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"25MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"25MG;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALSARTAN AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; VALSARTAN","actionType":"12.5MG;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; VALSARTAN","actionType":"12.5MG;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; VALSARTAN","actionType":"12.5MG;320MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; VALSARTAN","actionType":"25MG;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; VALSARTAN","actionType":"25MG;320MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)