ANDA 216223

LAURUS LABS LTD

FDA Drug Application

Application #216223

Application Sponsors

ANDA 216223

LAURUS LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

600MG;50MG;300MG

0

ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE

ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LAURUS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216223
            [companyName] => LAURUS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE","activeIngredients":"ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE","strength":"600MG;50MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-11
        )

)