HETERO LABS LTD V FDA Approval ANDA 203053

ANDA 203053

HETERO LABS LTD V

FDA Drug Application

Application #203053

Documents

Letter2013-11-06

Application Sponsors

ANDA 203053HETERO LABS LTD V

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET; ORAL600MG; 200MG; 300MG0EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATEEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

UNKNOWN; ORIG1TA2013-10-31

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAB

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203053
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"600MG; 200MG; 300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2013","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203053Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-10-31
        )

)

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