NDA 203382

SANDOZ INC

FDA Drug Application

Application #203382

Application Sponsors

NDA 203382

SANDOZ INC

Marketing Status

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

Application Products

001	TABLET;ORAL	150MG	0	MARAVIROC	MARAVIROC
002	TABLET;ORAL	300MG	0	MARAVIROC	MARAVIROC

FDA Submissions

UNKNOWN;

ORIG

1

TA

2014-12-08

Submissions Property Types

ORIG

1

Null

1

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203382
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MARAVIROC","activeIngredients":"MARAVIROC","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MARAVIROC","activeIngredients":"MARAVIROC","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/08\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-12-08
        )

)