NDA 202212

CIPLA LIMITED

FDA Drug Application

Application #202212

Documents

• Letter: 2012-05-03

Application Sponsors

NDA 202212

CIPLA LIMITED

Marketing Status

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

Application Products

001	TABLET, FOR SUSPENSION; ORAL	50MG	0	NEVIRAPINE	NEVIRAPINE
002	TABLET, FOR SUSPENSION; ORAL	100MG	0	NEVIRAPINE	NEVIRAPINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2012-04-30

STANDARD

Submissions Property Types

ORIG

1

Null

23

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202212
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"50MG","dosageForm":"TABLET, FOR SUSPENSION; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"100MG","dosageForm":"TABLET, FOR SUSPENSION; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/30\/2012","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202212Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-04-30
        )

)