ANDA 090815

ZYDUS PHARMS USA INC

FDA Drug Application

Application #090815

Application Sponsors

ANDA 090815

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET; ORAL	150MG; 12.5MG	0	IRBESARTAN; HYDROCHLOROTHIAZIDE	IRBESARTAN; HYDROCHLOROTHIAZIDE
002	TABLET; ORAL	300MG; 12.5MG	0	IRBESARTAN; HYDROCHLOROTHIAZIDE	IRBESARTAN; HYDROCHLOROTHIAZIDE
003	TABLET; ORAL	300MG; 25MG	0	IRBESARTAN; HYDROCHLOROTHIAZIDE	IRBESARTAN; HYDROCHLOROTHIAZIDE

FDA Submissions

ORIG

1

TA

2011-02-16

Submissions Property Types

ORIG

1

Null

0

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90815
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRBESARTAN; HYDROCHLOROTHIAZIDE","activeIngredients":"IRBESARTAN; HYDROCHLOROTHIAZIDE","strength":"150MG; 12.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"IRBESARTAN; HYDROCHLOROTHIAZIDE","activeIngredients":"IRBESARTAN; HYDROCHLOROTHIAZIDE","strength":"300MG; 12.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"IRBESARTAN; HYDROCHLOROTHIAZIDE","activeIngredients":"IRBESARTAN; HYDROCHLOROTHIAZIDE","strength":"300MG; 25MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IRBESARTAN; HYDROCHLOROTHIAZIDE","submission":"IRBESARTAN; HYDROCHLOROTHIAZIDE","actionType":"150MG; 12.5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"IRBESARTAN; HYDROCHLOROTHIAZIDE","submission":"IRBESARTAN; HYDROCHLOROTHIAZIDE","actionType":"300MG; 12.5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"IRBESARTAN; HYDROCHLOROTHIAZIDE","submission":"IRBESARTAN; HYDROCHLOROTHIAZIDE","actionType":"300MG; 25MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)