Documents
Application Sponsors
ANDA 212077 | SCIEGEN PHARMS INC | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | CAPSULE;ORAL | 267MG | 0 | PIRFENIDONE | PIRFENIDONE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2020-11-16 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
SCIEGEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212077
[companyName] => SCIEGEN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/16\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-11-16
)
)