Application 214264
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOFACITINIB | TOFACITINIB CITRATE | TABLET, EXTENDED RELEASE;ORAL | EQ 11MG BASE | No | No |
| 002 | TOFACITINIB | TOFACITINIB CITRATE | TABLET, EXTENDED RELEASE;ORAL | EQ 22MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68526 | ORIG | 2021-09-02 |