ANDA 208740

APOTEX INC

FDA Drug Application

Application #208740

Application Sponsors

ANDA 208740

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

200MG;300MG

0

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

EMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-04-15

UNKNOWN

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208740
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/15\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-15
        )

)