ANDA 091677

HETERO LABS LTD III

FDA Drug Application

Application #091677

Documents

• Letter: 2012-05-24

Application Sponsors

ANDA 091677

HETERO LABS LTD III

Marketing Status

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

Application Products

001	TABLET; ORAL	200MG; 50MG	0	LOPINAVIR; RITONAVIR	LOPINAVIR; RITONAVIR
002	TABLET;ORAL	200MG;50MG	0	LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR

FDA Submissions

ORIG

1

TA

2012-05-23

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91677
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPINAVIR; RITONAVIR","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"200MG; 50MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOPINAVIR; RITONAVIR","submission":"LOPINAVIR; RITONAVIR","actionType":"200MG; 50MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)