Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218668
Company: DEXCEL
Company: DEXCEL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOFACITINIB CITRATE | TOFACITINIB CITRATE | EQ 11MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| TOFACITINIB CITRATE | TOFACITINIB CITRATE | 22MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/16/2024 | ORIG-2 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218668Orig1s000ltr,218668Orig1s000TAltr.pdf | |
| 12/16/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218668Orig1s000ltr,218668Orig1s000TAltr.pdf |