LAURUS LABS LTD FDA Approval ANDA 216223

ANDA 216223

LAURUS LABS LTD

FDA Drug Application

Application #216223

Application Sponsors

ANDA 216223LAURUS LABS LTD

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET;ORAL600MG;50MG;300MG0ABACAVIR; DOLUTEGRAVIR; LAMIVUDINEABACAVIR;DOLUTEGRAVIR;LAMIVUDINE

FDA Submissions

UNKNOWN; ORIG1TA2022-08-11STANDARD

Submissions Property Types

ORIG1Null31

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
        )

)

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