ANDA 208057

TEVA PHARMS USA

FDA Drug Application

Application #208057

Documents

• Letter: 2017-07-13

Application Sponsors

ANDA 208057

TEVA PHARMS USA

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	CAPSULE;ORAL	EQ 75MG BASE	0	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE
002	CAPSULE;ORAL	110MG	0	DABIGATRAN ETEXILATE	DABIGATRAN ETEXILATE
003	CAPSULE;ORAL	150MG	0	DABIGATRAN ETEXILATE	DABIGATRAN ETEXILATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-04-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208057
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DABIGATRAN ETEXILATE","activeIngredients":"DABIGATRAN ETEXILATE","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DABIGATRAN ETEXILATE","activeIngredients":"DABIGATRAN ETEXILATE","strength":"110MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DABIGATRAN ETEXILATE","activeIngredients":"DABIGATRAN ETEXILATE","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208057TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-19
        )

)