HETERO LABS UNIT III FDA Approval NDA 202157

NDA 202157

HETERO LABS UNIT III

FDA Drug Application

Application #202157

Documents

Letter2011-11-29

Application Sponsors

NDA 202157HETERO LABS UNIT III

Marketing Status

None (Tentative Approval)001

Application Products

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

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1TA2011-11-18STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

HETERO LABS UNIT III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202157
            [companyName] => HETERO LABS UNIT III
            [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":"11\/18\/2011","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202157s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2011-11-18
        )

)

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