Application Sponsors
ANDA 212615 | GRANULES INDIA | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
001 | TABLET;ORAL | 267MG | 0 | PIRFENIDONE | PIRFENIDONE |
002 | TABLET;ORAL | 801MG | 0 | PIRFENIDONE | PIRFENIDONE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-05-12 | STANDARD |
Submissions Property Types
CDER Filings
GRANULES INDIA
cder:Array
(
[0] => Array
(
[ApplNo] => 212615
[companyName] => GRANULES INDIA
[docInserts] => ["",""]
[products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/12\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-05-12
)
)