ANDA 201616

CIPLA LIMITED

FDA Drug Application

Application #201616

Application Sponsors

ANDA 201616

CIPLA LIMITED

Marketing Status

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

Application Products

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

FDA Submissions

ORIG

1

TA

2012-09-28

Submissions Property Types

ORIG

1

Null

0

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201616
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE; IRBESARTAN","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG; 150MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCHLOROTHIAZIDE; IRBESARTAN","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG; 300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/28\/2012","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-09-28
        )

)