ANDA 202728

TORRENT

FDA Drug Application

Application #202728

Application Sponsors

ANDA 202728

TORRENT

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

UNKNOWN;	ORIG	1	AP	2015-01-05
LABELING; Labeling	SUPPL	3	AP	2015-11-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-06-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-06-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-12-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202728
            [companyName] => TORRENT
            [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":"01\/05\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/30\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/20\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-30
        )

)