ANDA 203586

ECI PHARMS LLC

FDA Drug Application

Application #203586

Documents

• Letter: 2015-02-17

Application Sponsors

ANDA 203586

ECI PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

150MG

0

LAMIVUDINE

LAMIVUDINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-21

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

PHARMA LIFE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203586
            [companyName] => PHARMA LIFE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/21\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203586Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-21
        )

)