Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2019-09-30 | STANDARD |
Submissions Property Types
CDER Filings
APOTEX INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212709
[companyName] => APOTEX INC
[docInserts] => ["",""]
[products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/30\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212709Orig1s000_TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-09-30
)
)