ANDA 213038

LAURUS LABS LTD

FDA Drug Application

Application #213038

Documents

• Letter: 2020-06-08

Application Sponsors

ANDA 213038

LAURUS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

400MG;300MG;300MG

0

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-05-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LAURUS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213038
            [companyName] => LAURUS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"400MG;300MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213038Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-14
        )

)