Application Sponsors
ANDA 206167 | TEVA PHARMS USA INC | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
001 | INJECTABLE;INJECTION | 20MG/1ML | 0 | PRALATREXATE | PRALATREXATE |
002 | INJECTABLE;INJECTION | 40MG/2ML | 0 | PRALATREXATE | PRALATREXATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2016-01-21 | STANDARD |
Submissions Property Types
CDER Filings
TEVA PHARMS USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 206167
[companyName] => TEVA PHARMS USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"PRALATREXATE","activeIngredients":"PRALATREXATE","strength":"20MG\/1ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PRALATREXATE","activeIngredients":"PRALATREXATE","strength":"40MG\/2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/21\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-01-21
)
)