ANDA 203759

CIPLA LTD

FDA Drug Application

Application #203759

Application Sponsors

ANDA 203759

CIPLA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

100MG

2

RITONAVIR

RITONAVIR

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-03-27

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203759
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RITONAVIR","activeIngredients":"RITONAVIR","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/27\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-03-27
        )

)