ANDA 090642

WATSON LABS INC

FDA Drug Application

Application #090642

Application Sponsors

ANDA 090642

WATSON LABS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	40MG	0	VALSARTAN	VALSARTAN
002	TABLET;ORAL	80MG	0	VALSARTAN	VALSARTAN
003	TABLET;ORAL	160MG	0	VALSARTAN	VALSARTAN
004	TABLET;ORAL	320MG	0	VALSARTAN	VALSARTAN

FDA Submissions

	ORIG	1	AP	2015-01-05
LABELING; Labeling	SUPPL	5	AP	2020-06-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-06-30	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	5	Null	15
SUPPL	7	Null	15

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90642
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALSARTAN","submission":"VALSARTAN","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN","submission":"VALSARTAN","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN","submission":"VALSARTAN","actionType":"160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN","submission":"VALSARTAN","actionType":"320MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)