ANDA 091055

STRIDES ARCOLAB LTD

FDA Drug Application

Application #091055

Documents

• Letter: 2013-08-05

Application Sponsors

ANDA 091055

STRIDES ARCOLAB LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

200MG; 300MG

0

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

ORIG

1

TA

2013-07-31

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

STRIDES ARCOLAB LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91055
            [companyName] => STRIDES ARCOLAB LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"200MG; 300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","submission":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","actionType":"200MG; 300MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)