ANDA 209938

TEVA PHARMS USA INC

FDA Drug Application

Application #209938

Application Sponsors

ANDA 209938

TEVA PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET;ORAL	12.5MG	0	ELTROMBOPAG	ELTROMBOPAG
002	TABLET;ORAL	25MG	0	ELTROMBOPAG	ELTROMBOPAG
003	TABLET;ORAL	75MG	0	ELTROMBOPAG	ELTROMBOPAG

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-02-16

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209938
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELTROMBOPAG","activeIngredients":"ELTROMBOPAG","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ELTROMBOPAG","activeIngredients":"ELTROMBOPAG","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ELTROMBOPAG","activeIngredients":"ELTROMBOPAG","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/16\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-16
        )

)