ANDA 204739

MACLEODS PHARMS LTD

FDA Drug Application

Application #204739

Application Sponsors

ANDA 204739

MACLEODS PHARMS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	100MG;25MG	0	LOPINAVIR; RITONAVIR	LOPINAVIR;RITONAVIR
002	TABLET;ORAL	200MG;50MG	0	LOPINAVIR; RITONAVIR	LOPINAVIR;RITONAVIR

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-03-07

Submissions Property Types

ORIG

1

Null

1

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204739
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPINAVIR; RITONAVIR","activeIngredients":"LOPINAVIR;RITONAVIR","strength":"100MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"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":"03\/07\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-07
        )

)