NDA 205508

EMCURE PHARMS LTD

FDA Drug Application

Application #205508

Documents

• Letter: 2014-03-19

Application Sponsors

NDA 205508

EMCURE PHARMS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

300MG; 100MG

0

ATAZANAVIR SULFATE; RITONAVIR

ATAZANAVIR SULFATE; RITONAVIR

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2014-03-17

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205508
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATAZANAVIR SULFATE; RITONAVIR","activeIngredients":"ATAZANAVIR SULFATE; RITONAVIR","strength":"300MG; 100MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/17\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205508Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-03-17
        )

)