ANDA 208046

ALEMBIC PHARMS LTD

FDA Drug Application

Application #208046

Documents

• Letter: 2017-07-13

Application Sponsors

ANDA 208046

ALEMBIC PHARMS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

EQ 150MG BASE

0

DABIGATRAN ETEXILATE MESYLATE

DABIGATRAN ETEXILATE MESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-07-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208046
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DABIGATRAN ETEXILATE","activeIngredients":"DABIGATRAN ETEXILATE","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/07\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208046TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-07
        )

)