Application 213176
- Type
- NDA
- Sponsor
- TG THERAPEUTICS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | UKONIQ | UMBRALISIB TOSYLATE | TABLET;ORAL | 200MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73150-200 | UKONIQ | umbralisib | TG Therapeutics, Inc. | NDA | Current |
| 73150-200 | UKONIQ | umbralisib | TG Therapeutics, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66562 | ORIG | 2021-03-05 |
| 66145 | ORIG | 2021-02-09 |
| 66144 | ORIG | 2021-02-09 |
| 66111 | ORIG | 2021-02-05 |
| 66110 | ORIG | 2021-02-05 |
| 66109 | ORIG | 2021-02-05 |