ANDA 091654

TORRENT PHARMS LTD

FDA Drug Application

Application #091654

Application Sponsors

ANDA 091654

TORRENT PHARMS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005

Application Products

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

FDA Submissions

ORIG

1

TA

2012-04-10

Submissions Property Types

ORIG

1

Null

0

CDER Filings

TORRENT PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91654
            [companyName] => TORRENT PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALSARTAN; HYDROCHLOROTHIAZIDE","activeIngredients":"VALSARTAN; HYDROCHLOROTHIAZIDE","strength":"80MG; 12.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN; HYDROCHLOROTHIAZIDE","activeIngredients":"VALSARTAN; HYDROCHLOROTHIAZIDE","strength":"160MG; 12.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN; HYDROCHLOROTHIAZIDE","activeIngredients":"VALSARTAN; HYDROCHLOROTHIAZIDE","strength":"160MG; 25MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN; HYDROCHLOROTHIAZIDE","activeIngredients":"VALSARTAN; HYDROCHLOROTHIAZIDE","strength":"320MG; 12.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN; HYDROCHLOROTHIAZIDE","activeIngredients":"VALSARTAN; HYDROCHLOROTHIAZIDE","strength":"320MG; 25MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALSARTAN; HYDROCHLOROTHIAZIDE","submission":"VALSARTAN; HYDROCHLOROTHIAZIDE","actionType":"80MG; 12.5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN; HYDROCHLOROTHIAZIDE","submission":"VALSARTAN; HYDROCHLOROTHIAZIDE","actionType":"160MG; 12.5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN; HYDROCHLOROTHIAZIDE","submission":"VALSARTAN; HYDROCHLOROTHIAZIDE","actionType":"160MG; 25MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN; HYDROCHLOROTHIAZIDE","submission":"VALSARTAN; HYDROCHLOROTHIAZIDE","actionType":"320MG; 12.5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN; HYDROCHLOROTHIAZIDE","submission":"VALSARTAN; HYDROCHLOROTHIAZIDE","actionType":"320MG; 25MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)