ANDA 202083

HETERO LABS UNIT III

FDA Drug Application

Application #202083

Application Sponsors

ANDA 202083

HETERO LABS UNIT III

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	TABLET;ORAL	400MG	0	DARUNAVIR	DARUNAVIR
002	TABLET;ORAL	600MG	0	DARUNAVIR	DARUNAVIR
003	TABLET;ORAL	150MG	0	DARUNAVIR	DARUNAVIR
004	TABLET;ORAL	300MG	0	DARUNAVIR	DARUNAVIR

FDA Submissions

N/A; Not Applicable

ORIG

1

TA

2014-10-07

Submissions Property Types

ORIG

1

Null

17

CDER Filings

HETERO LABS UNIT III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202083
            [companyName] => HETERO LABS UNIT III
            [docInserts] => ["",""]
            [products] => [{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/07\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-10-07
        )

)