Application Sponsors
ANDA 206788 | HETERO LABS LTD V | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
None (Tentative Approval) | 004 |
Application Products
001 | TABLET;ORAL | 12.5MG | 0 | ELTROMBOPAG | ELTROMBOPAG |
002 | TABLET;ORAL | 25MG | 0 | ELTROMBOPAG | ELTROMBOPAG |
003 | TABLET;ORAL | 50MG | 0 | ELTROMBOPAG | ELTROMBOPAG |
004 | TABLET;ORAL | 75MG | 0 | ELTROMBOPAG | ELTROMBOPAG |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2016-07-06 | STANDARD |
Submissions Property Types
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
)
)