ANDA 090371

CIPLA LIMITED

FDA Drug Application

Application #090371

Documents

• Letter: 2009-11-24

Application Sponsors

ANDA 090371

CIPLA LIMITED

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

200MG; 50MG

0

LOPINAVIR; RITONAVIR

LOPINAVIR; RITONAVIR

FDA Submissions

ORIG

1

TA

2009-11-20

Submissions Property Types

ORIG

1

Null

1

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90371
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPINAVIR; RITONAVIR","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"200MG; 50MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOPINAVIR; RITONAVIR","submission":"LOPINAVIR; RITONAVIR","actionType":"200MG; 50MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)