NDA 205425

CIPLA LTD

FDA Drug Application

Application #205425

Documents

• Letter: 2015-05-22

Application Sponsors

NDA 205425

CIPLA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

PELLETS;ORAL

40MG;10MG

0

LOPINAVIR AND RITONAVIR

LOPINAVIR;RITONAVIR

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2015-05-21

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205425
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPINAVIR AND RITONAVIR","activeIngredients":"LOPINAVIR;RITONAVIR","strength":"40MG;10MG","dosageForm":"PELLETS;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205425Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-05-21
        )

)