Application Sponsors
ANDA 204869 | STRIDES PHARMA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 600MG | 0 | EFAVIRENZ | EFAVIRENZ |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-03-12 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 204869
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/12\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-03-12
)
)