STRIDES ARCOLAB LTD FDA Approval NDA 022464

NDA 022464

STRIDES ARCOLAB LTD

FDA Drug Application

Application #022464

Documents

Letter2010-01-05

Application Sponsors

NDA 022464STRIDES ARCOLAB LTD

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET; ORAL150MG; 200MG; 300MG0LAMIVUDINE; NEVIRAPINE; ZIDOVUDINELAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1TA2009-12-22STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

STRIDES ARCOLAB LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22464
            [companyName] => STRIDES ARCOLAB LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","activeIngredients":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","strength":"150MG; 200MG; 300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","submission":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","actionType":"150MG; 200MG; 300MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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