ANDA 201806

HETERO LABS UNIT III

FDA Drug Application

Application #201806

Application Sponsors

ANDA 201806

HETERO LABS UNIT III

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

200MG; 300MG

0

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

N/A; Not Applicable

ORIG

1

TA

2011-12-22

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201806
            [companyName] => HETERO LABS LTD III
            [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":"10\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-07
        )

)