| TOFACITINIB |
218437 |
002 |
ANDA |
TOFACITINIB |
TABLET |
5MG |
No
|
No
|
2024/12/27
(TA)
|
--
|
ANNORA PHARMA PRIVATE LIMITED |
None (Tentative Approval) |
| TOFACITINIB CITRATE |
219542 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/08/19
|
2025/08/19
|
AJANTA PHARMA LTD |
Prescription |
| TOFACITINIB CITRATE |
219542 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/08/19
(TA)
|
2025/08/19
|
AJANTA PHARMA LTD |
Prescription |
| TOFACITINIB |
215356 |
002 |
ANDA |
TOFACITINIB |
TABLET |
5MG |
No
|
No
|
2025/09/17
(TA)
|
--
|
AUROBINDO PHARMA LIMITED |
None (Tentative Approval) |
| TOFACITINIB CITRATE |
216001 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/09/30
|
2025/09/30
|
SINOTHERAPEUTICS INC |
Prescription |
| TOFACITINIB CITRATE |
216001 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/09/30
(TA)
|
2025/09/30
|
SINOTHERAPEUTICS INC |
Prescription |
| TOFACITINIB CITRATE |
219442 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/11/17
|
--
|
BIOCON PHARMA |
Prescription |
| TOFACITINIB CITRATE |
219442 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/11/17
(TA)
|
--
|
BIOCON PHARMA |
Prescription |
| TOFACITINIB CITRATE |
219442 |
002 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 22MG BASE |
No
|
No
|
2025/11/17
|
--
|
BIOCON PHARMA |
None (Tentative Approval) |
| TOFACITINIB CITRATE |
219442 |
002 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 22MG BASE |
No
|
No
|
2025/11/17
(TA)
|
--
|
BIOCON PHARMA |
None (Tentative Approval) |