New Drug Application (NDA): 213176
Company: TG THERAPEUTICS INC
Company: TG THERAPEUTICS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UKONIQ | UMBRALISIB TOSYLATE | 200MG | TABLET;ORAL | Prescription | None | TBD | 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 | Type 1 - New Molecular Entity | PRIORITY; 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) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213176s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213176Orig1s000, 213176Orig2s000ltr.pdf |
| 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 |