HETERO LABS LTD V FDA Approval ANDA 206788

ANDA 206788

HETERO LABS LTD V

FDA Drug Application

Application #206788

Application Sponsors

ANDA 206788HETERO LABS LTD V

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004

Application Products

001TABLET;ORAL12.5MG0ELTROMBOPAGELTROMBOPAG
002TABLET;ORAL25MG0ELTROMBOPAGELTROMBOPAG
003TABLET;ORAL50MG0ELTROMBOPAGELTROMBOPAG
004TABLET;ORAL75MG0ELTROMBOPAGELTROMBOPAG

FDA Submissions

UNKNOWN; ORIG1TA2016-07-06STANDARD

Submissions Property Types

ORIG1Null1

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206788
            [companyName] => HETERO LABS LTD V
            [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":"50MG","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":"07\/06\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-07-06
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.