NDA 205040

CIPLA LIMITED

FDA Drug Application

Application #205040

Documents

• Letter: 2015-04-03

Application Sponsors

NDA 205040

CIPLA LIMITED

Marketing Status

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

Application Products

001	TABLET; ORAL	25MG	2	RITONAVIR	RITONAVIR
002	TABLET; ORAL	50MG	0	RITONAVIR	RITONAVIR

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2015-03-29

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205040
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"RITONAVIR","activeIngredients":"RITONAVIR","strength":"25MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"TBD","rs":"No"},{"drugName":"RITONAVIR","activeIngredients":"RITONAVIR","strength":"50MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/29\/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\\\/205040Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-03-29
        )

)