Documents
Application Sponsors
ANDA 214264 | ZYDUS PHARMS USA INC | |
Marketing Status
None (Tentative Approval) | 001 |
Prescription | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | EQ 11MG BASE | 0 | TOFACITINIB | TOFACITINIB CITRATE |
002 | TABLET, EXTENDED RELEASE;ORAL | EQ 22MG BASE | 0 | TOFACITINIB | TOFACITINIB CITRATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2020-10-16 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
ZYDUS PHARMS USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 214264
[companyName] => ZYDUS PHARMS USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"TOFACITINIB","activeIngredients":"TOFACITINIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/16\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-10-16
)
)