ZYDUS PHARMS FDA Approval ANDA 212689

ANDA 212689

ZYDUS PHARMS

FDA Drug Application

Application #212689

Documents

Letter2020-03-23

Application Sponsors

ANDA 212689ZYDUS PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL200MG;300MG0EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
002TABLET;ORAL100MG;150MG0EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
003TABLET;ORAL133MG;200MG0EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
004TABLET;ORAL167MG;250MG0EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2020-02-28STANDARD
UNKNOWN; ORIG2TA2020-02-28STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212689
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"200MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212689Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-28
        )

)

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