Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213176
Company: TG THERAPS
Company: TG THERAPS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UKONIQ | UMBRALISIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 02/05/2021 | ORIG-2 | Approval | Efficacy | STANDARD; Orphan |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213176s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213176Orig1s000, 213176Orig2s000ltr.pdf | |
| 02/05/2021 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213176s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213176Orig1s000, 213176Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213176Orig1Orig2s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/05/2021 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213176s000lbl.pdf | |
| 02/05/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213176s000lbl.pdf |